Intellia believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Vice President, Quality Management Systems and Digital Compliance
Location
United States
Posted
1 day ago
Salary
$319.1K - $390.0K / year
Seniority
Mid Level
No structured requirement data.
Job Description
Vice President, Quality Management Systems and Digital Compliance
Intellia Therapeutics, Inc.
Role Description The Vice President of Quality Management Systems is responsible for defining and executing the enterprise-wide quality vision that enables organizational growth from clinical development through commercial operations. This position drives digital transformation through eQMS implementation, establishes robust governance frameworks, and ensures sustained regulatory compliance and inspection readiness. The role will develop and lead a high-performing quality team focusing on a culture of quality excellence and serve as a strategic partner to executive leadership across R&D, Manufacturing, Regulatory Affairs, and Commercial Operations. Responsibilities - Define and execute enterprise-wide QMS strategy aligned with corporate objectives and growth plans - Serve as executive sponsor for quality system transformation initiatives supporting commercialization readiness - Lead long-term strategic planning for quality infrastructure investments, technology roadmaps, and organizational capability building - Anticipate regulatory trends and proactively position the organization to meet evolving compliance requirements - Champion quality excellence as a competitive differentiator and driver of business value - Lead enterprise-wide quality transformation and change management initiatives - Establish governance structures, decision-making frameworks, and accountability models across the quality system - Build organizational consensus on quality priorities and resource allocation - Represent Quality in executive forums, strategic planning sessions, and board presentations - Design, implement, and scale comprehensive quality systems from clinical through commercial stages - Establish QMS governance framework ensuring compliance with regulatory requirements, industry standards, and company policies - Own the Quality Management System strategic roadmap with multi-year planning horizons supporting pipeline expansion and future innovations - Provide executive oversight for critical quality processes including Deviations, CAPA, Change Control, Document Control, Complaints, Quality Risk Management, and Data Integrity programs - Chair Quality Management Review processes, presenting system metrics, trends, and strategic recommendations to executive leadership - Establish quality intelligence and analytics capabilities to drive data-informed decisions - Drive continuous improvement initiatives and define KPIs that measure quality system performance and business impact - Lead enterprise digital transformation through adoption, validation, and optimization of electronic Quality Management Systems (eQMS) - Oversee IT Quality, Computer System Validation (CSV), and Data Integrity programs ensuring compliance with 21 CFR Part 11, Annex 11, and GAMP 5 - Champion strategic vision for Data Governance & Integrity programs, including AI/ML quality applications and digital innovation - Ensure enterprise-wide readiness for global regulatory inspections and Pre-Approval Inspections (PAIs) - Lead critical health authority inspections and third-party GMP audits - Support regulatory submission strategies and authoring of product licenses and regulatory dossiers - Establish enterprise risk management framework integrating quality risk into corporate risk management processes - Define enterprise quality metrics and drive operational effectiveness through data analytics - Champion quality by design (QbD) and risk-based thinking - Develop and oversee risk-based approaches for quality system governance - Ensure proactive identification and mitigation of compliance risks - Define common global effectiveness and efficiency metrics to drive end-to-end performance - Implement key performance indicators (KPIs) to monitor QMS effectiveness and enable data-driven decision-making - Build, develop, and lead a high-performing organization of quality professionals - Foster a culture of accountability, innovation, and continuous improvement - Provide executive coaching and mentorship to quality leaders - Champion diversity, equity, and inclusion initiatives and drive organizational effectiveness through structure optimization and talent acquisition - Serve as strategic partner to R&D, Technical Operations, Supply Chain, Regulatory Affairs, and Commercial Operations leadership - Collaborate with Legal, Finance, and Corporate Development on compliance risk management, due diligence, and integration activities - Partner with Human Resources on quality training strategy, organizational design, and change management - Build external relationships with industry associations, regulatory agencies, and peer organizations Qualifications - Expert-level knowledge of global health authority regulations including FDA, EMA, PMDA, and ROW requirements for pharmaceuticals and ATMPs - Deep expertise in ICH guidelines (Q8, Q9, Q10, Q11), 21 CFR Part 11, EU GMP Annex 11, and emerging regulatory frameworks - Proven expertise leading digital transformation initiatives including eQMS implementation, validation, and optimization - Strong knowledge of Computer System Validation, data integrity, and digital compliance requirements - Understanding of quality requirements across multiple product types (biologics, ATMPs) preferred - Advanced expertise in quality management methodologies including Lean Six Sigma (Black Belt preferred), FMEA, Root Cause Analysis - Strong proficiency with data analytics, business intelligence tools, and quality metrics dashboards - Understanding of emerging technologies including AI/ML applications in quality, digital twins, and predictive analytics - Knowledge of industry risk management concepts and their application to quality management - BS, MS, or PhD in a field of science, engineering, pharmacy, or medicine - 15-20+ years quality leadership in Cell & Gene Therapy, biotech, or pharmaceutical industry with 10+ years managing quality systems and compliance function - Direct experience leading multiple successful regulatory approvals and commercial launches - Expert knowledge of FDA, EMA, and global health authority regulations - Proven track record leading regulatory inspections - Extensive experience implementing enterprise-wide eQMS and digital transformation initiatives - Demonstrated success scaling quality organizations from clinical through commercial phases - Strategic business acumen to translate quality into competitive advantage - Ability to lead organizational transformation and drive cultural change - Executive presence with proven ability to influence across all organizational levels - Experience managing quality teams through high-growth environments - Deep knowledge of ICH guidelines, 21 CFR Part 11, EU GMP Annex 11 - Strong expertise in data integrity, Computer System Validation, and digital compliance - Advanced quality methodologies (Lean Six Sigma, FMEA, Root Cause Analysis) - Experience with emerging technologies (AI/ML in quality, predictive analytics) Benefits - Performance-based annual cash bonus - New hire equity grant - Eligibility for annual equity awards EEOC Statement Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Related Guides
Related Categories
Related Job Pages
More Vice President Jobs
• build, lead, and scale SS&C Blue Prism's indirect go-to-market motion across North America • design and execute the North America partner strategy • recruit, develop, and manage a high-performing team of channel sales professionals • collaborate with direct sales, marketing, product, and customer success teams • own and deliver the North America channel-sourced ARR targets • establish a high-performance culture rooted in accountability and partner value
Vice President, Specialist Sales (Digital Payments)
MastercardFounded in 1966, Mastercard is a worldwide transaction, payment-processing, and consulting company best known for its line of personal and business credit cards. As an employer, Ma
Our Purpose Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart and accessible. Our technology and innovation, partnerships and networks combine to deliver a unique set of products and services that help people, businesses and governments realize their greatest potential. Title and Summary Vice President, Specialist Sales (Digital Payments) Overview The Customer Solution Center (CSC) team enables Mastercard to develop stronger solutions and bundles for customer segments across markets. It serves as the central hub for all Mastercard capabilities, aiming to drive growth, influence, and revenue by creating and delivering compelling, data-driven, and scalable needs-based solutions to both new and existing customers-leveraging Mastercard's extensive portfolio of products and services. Under the CSC, the Digital Payments' team vision is to create a world beyond plastic through a combination of technology and strategic partnerships. We are creating safe and secure experiences for consumers across all channels and all devices, enabling issuers and merchants to reach new consumers. • The team is expected to work with banks, merchants, and digital participants to enable consumers to use connected devices for everyday shopping and payments. • The individual will be responsible for accelerating digital payments across the division and the role encompasses: o Tokenization and authentication across devices, issuers, and merchants o Driving digital payments through innovation solutions o Improving x-pays penetration and driving a SEA based digital-first agenda • Do you want to help create the future of Mastercard and of payments?• Are you motivated to be a part of driving a world beyond cash and plastic?• Do you want to be part of a diverse and exciting team? Role This role requires the candidate to: - Lead the Mastercard Digital Payments team for Southeast Asia - Drive the commercialization and adoption of Mastercard's Digital Payment solutions across issuers, acquirers, PSPs, fintechs, and merchants in Southeast Asia. - Identify and unlock revenue growth opportunities with customers, with a strong focus on improving approval rates, reducing fraud, and optimizing checkout conversion. - Lead client engagements at a senior level, including workshops and solutioning sessions, to define use cases, address gaps, and position Mastercard's differentiated value proposition. Be able to lead discussions with regulators and card association bodies. - Translate Mastercard's global digital vision into actionable market strategies, with a focus on scaling tokenized transactions, digital-first experiences, and frictionless authentication within a rapidly evolving ecosystem. - Collaborate cross-functionally with Account Sales, Product, Delivery, Digital Partnerships, Legal, and Compliance to execute market initiatives and strategic programs. - Embed data-driven insights and performance tracking into all engagements, ensuring continuous optimization of client outcomes and Mastercard business impact. - Engage with Mastercard management to develop a strategic direction for Mastercard digital products and services. - Coordinate digital strategy, integration and deployment with the regional teams. - Be a motivational team leader who can lead the team and ensure they are successful in meeting market target All About You - MBA or master's degree required - Deep experience in the digital payments space in Southeast Asia with proven success in bringing products to market and generating adoption. - Proven ability to effectively manage a team in the digital payments business - Proven ability to develop complex strategic go-to-market plans and execute on those plans. - In-depth understanding of the payments ecosystem both in Southeast Asia including tokenization, fast ACH (UPI), push payments - Operational understanding of payments technologies - Ability to leverage technical knowledge & real-world experience to solve complex business problems. - Proven ability to build and maintain strong, productive working relationships with internal stakeholders and external customers - Experience working with issuers, acquirers, PSPs, fintechs, or digital merchants is highly preferred. - Strategic thinker with a collaborative working style and the ability to manage multiple stakeholders and priorities effectively. Corporate Security Responsibility All activities involving access to Mastercard assets, information, and networks comes with an inherent risk to the organization and, therefore, it is expected that every person working for, or on behalf of, Mastercard is responsible for information security and must: - Abide by Mastercard's security policies and practices; - Ensure the confidentiality and integrity of the information being accessed; - Report any suspected information security violation or breach, and - Complete all periodic mandatory security trainings in accordance with Mastercard's guidelines.
• Lead the development and execution of the Technology Applications audit strategy, focusing on evaluating the effectiveness and efficiency of Technology Applications, Systems, and Processes. • Ensure compliance with regulatory and industry standards, and identify areas for improvement to enhance the overall Technology and Information Security controls within the Bank. • Collaborate with Internal Audit senior management to design a risk-based audit coverage strategy, set audit priorities, and deliver independent evaluations of the technology applications audit process. • Work alongside other audit seniors to provide technological support for comprehensive bank-wide integrated audits. • Recognize emerging risks by engaging with business units to understand organizational changes, and conducting risk assessments in these areas. • Establish the scope and objectives for technology application audits to ensure alignment with industry best practices. • Assess internal controls within critical technology risk domains to guarantee adherence to internal policies and relevant laws and regulations. • Provide guidance to management regarding new developments impacting the portfolio or controls and offer proactive solutions. • Carry out technology audits by examining the design and operational effectiveness of controls, ensuring compliance, and pinpointing weaknesses and vulnerabilities. • Set performance standards and evaluate whether these standards and deadlines are met. • Oversee audit work, ensuring it follows the planned methodology and is completed within the agreed timeframes. • Counsel and guide auditors to ensure that the approved audit objectives are met and adequate coverage is achieved. • Develop team skills by identifying training needs and ensure that subordinates keep abreast of professional developments. • Identify and assess technology-related risk, evaluate the adequacy and effectiveness of internal controls, security measures, and operation resilience, ensuring appropriate controls are in place to mitigate potential risks. • Prepare comprehensive audit reports detailing findings and management action, present audit results to senior management including key risk areas, control deficiencies and opportunities for improvement. • Maintain updated industry knowledge and requirements, ensure that subordinates are kept abreast of professional developments, monitors professional development programs for assigned employees. • Communicate complex technical concepts and audit findings in a clear and concise manner to non-technical stakeholders. • Support the creation of excellence and high performance organization culture by embedding learning and creativity, in order to incorporate agility to accelerate transformation. • Review and assess the adequacy and effectiveness of the bank's IT controls related to advanced digital footprint, including but not limited to, cloud, API, microservices, and emerging technologies.
VP, Due Diligence and Onboarding
MVB BankMVB Bank is a community-focused financial institution headquartered in Fairmont, West Virginia, and operates as the primary subsidiary of MVB Financial Corp., a
Role Description The VP, Due Diligence and Onboarding reports directly to the SVP, Head of Enterprise Compliance Operations and is responsible for the operational execution, and continuous improvement of MVB Bank's customer and partner onboarding, Know Your Customer (KYC), and Due Diligence (DD) functions using compliance frameworks and risk criteria designed by Enterprise Compliance Advisory. This role owns the daily lifecycle of the due diligence process — from initial customer and fintech partner intake through ongoing risk-based review — and is accountable for the operational performance, quality, and regulatory integrity of the Onboarding & Due Diligence Team. The VP leads a multi-functional team covering KYC Due Diligence (DD), Customer Identification Program (CIP), and fintech partner onboarding. The role operates at the intersection of compliance rigor and operational efficiency, with direct accountability for staffing, workflow design, technology utilization, and exam readiness. This role serves as the primary subject matter expert on KYC/DD matters, representing the function in regulatory examinations, internal audits, and cross-functional governance forums and represents Operations at the executive level within Enterprise Compliance Committee and related governance bodies. Qualifications - 12-15+ years of progressive experience in BSA/AML compliance, with substantial tenure in KYC, DD, and customer or fintech partner onboarding functions at a federally regulated financial institution. - 9-10 years of direct management experience leading compliance operations teams with demonstrated accountability for team performance, quality output, and regulatory outcomes. - Bachelor's degree required; advanced degree in Finance, Business Administration, Law, or a related field preferred. Equivalent experience considered. - Deep subject matter expertise in KYC/DD requirements, CIP obligations, beneficial ownership rules, and the risk-based approach to customer due diligence as reflected in the FFIEC BSA/AML Examination Manual. - Demonstrated experience operating in a fintech partnership environment, with working knowledge of fintech business models, payment systems, and the compliance obligations associated with banking fintech partners. - Strong working knowledge of applicable laws, rules, and regulations including the Bank Secrecy Act, USA PATRIOT Act, FinCEN CDD Rule (31 C.F.R. § 1010.230), OFAC requirements, and FinCEN beneficial ownership guidance. - Experience leading or substantially contributing to regulatory examinations, internal audits, and BSA/AML program assessments, including preparation of examination materials and management of findings. - Proven ability to design and improve compliance operations at an operational level. - Experience with identity verification technologies, adverse media screening, sanctions screening tools, and risk management platforms (e.g., LogicGate, RiskCanvas, or equivalents). - Familiarity with AI and automation applications in compliance workflows, including digital worker deployments and model governance considerations. - CAMS (Certified Anti-Money Laundering Specialist) or equivalent professional certification strongly preferred. CGSS, CFCS, or CKYCA designations are also valued. - Exceptional written and verbal communication skills with the ability to present complex compliance topics clearly to regulators, senior leadership, and operational teams. Requirements - Own and drive the day-to-day operations of the Onboarding & Due Diligence function, ensuring efficient, compliant, and scalable execution across KYC, DD, and CIP workflows. - Lead and develop a high-performing team of due diligence analysts, reviewers, and managers; establish clear performance expectations, coaching frameworks, and career development pathways. - Define and enforce staffing models, workload distribution, and capacity planning across the function to ensure the team can meet volume, quality, and timeliness targets across all program types. - Establish, monitor, and continuously improve service level agreements (SLAs), quality metrics, and operational KPIs for the onboarding and due diligence lifecycle. - Partner with the Quality Control function to design and maintain robust QC sampling methodologies, quality scoring frameworks, and feedback loops that drive analyst performance and consistency. - Drive a culture of operational excellence — identifying and remediating workflow bottlenecks, eliminating rework, and leveraging automation and digital worker capabilities to improve throughput without degrading control quality. - Receive and execute compliance frameworks designed by Enterprise Compliance Advisory including customer risk rating methodology, Due Diligence criteria, partnership assessment frameworks, and ongoing monitoring requirements. - Coordinate daily with Advisory (BSA/AML Advisory, Consumer Compliance Advisory, Fraud Advisory) on complex customer cases, partnership assessments, and framework clarification questions. - Provide operational feedback to Advisory on framework effectiveness, practical implementation challenges, and continuous improvement opportunities through Enterprise Compliance Committee. - Serve as a standing voting/advisory member of Enterprise Compliance Committee representing Operations perspective, validating operational feasibility of proposed Advisory frameworks before implementation, and voicing resource constraints when frameworks exceed operational capacity. - Implement framework updates designed by Advisory including risk rating methodology changes, DD criteria revisions, or partnership monitoring requirement updates. - Serve as the operational owner for MVB's KYC, Onboarding, and DD programs, implementing compliance frameworks and risk criteria designed by Enterprise Compliance Advisory and ensuring all operational procedures, job aids, and execution standards reflect current regulatory requirements and Advisory-established risk parameters. - Oversee the execution of risk-based due diligence frameworks for all customer and partner relationship types, including standard CDD, EDD for high-risk customers, and specialized EDD for restricted customer categories (e.g., cannabis-related businesses, NBFIs, PEPs, tribal entities). - Ensure Due Diligence procedures are consistently and correctly applied for all high-risk and elevated-risk relationships, with documented rationale, appropriate escalation pathways, and timely completion. - Manage the ongoing periodic review program for fintech partners — establishing review cadences, coordinating review execution, and ensuring findings are documented and tracked to resolution. - Oversee beneficial ownership identification and verification processes in compliance with FinCEN's Beneficial Ownership Rule (31 C.F.R. § 1010.230) and Customer Due Diligence requirements. - Lead the development and maintenance of DD checklists, job aids, and narrative quality standards that enable consistent, exam-ready documentation across all analyst levels. - Lead the operational execution of MVB's fintech partner onboarding due diligence program using partnership assessment frameworks designed by Enterprise Compliance Advisory, ensuring all new fintech partners complete comprehensive operational due diligence including KYB verification, beneficial ownership identification, financial condition review, operational capability assessment, and compliance program evaluation. - Coordinate with Advisory on fintech partnership onboarding: Operations executes partnership KYB and operational TPRM due diligence while Advisory coordinates integrated strategic compliance assessment (AML + Consumer Compliance + Fraud); Operations provides due diligence findings to Advisory for strategic risk evaluation and partnership approval decision. - Execute partnership periodic review program conducting annual operational TPRM reviews of existing fintech partners per Advisory-established review framework. - Escalate partnership risk concerns identified during operational monitoring or annual reviews to Advisory for strategic assessment and potential partnership risk rating changes or exit recommendations. - Oversee the execution of fintech partner risk assessments, including business model analysis, compliance program review, fund flow documentation, and control effectiveness evaluation. - Collaborate with Enterprise Compliance Advisory Team to ensure fintech partnership relationships are documented with appropriate controls, including restrictions, program-specific DD requirements, and ongoing monitoring protocols. - Support the change request process for existing fintech partners, ensuring the risk of material program changes are assessed, documented, and approved prior to implementation. - Oversee MVB's Customer Identification Program in accordance with the USA PATRIOT Act, FinCEN CDD Rule, and FFIEC examination guidance, ensuring all identity verification requirements are met at onboarding and on an ongoing basis. - Ensure identity verification solutions, documentary and non-documentary verification methods, and recordkeeping requirements are properly implemented and consistently applied across all customer and partner onboarding channels. - Ensure compliance with CIP procedures and associated job aids, and coordinate with technology and vendor management teams to ensure identity verification tools perform as intended. - Oversee CIP escalations team handling complex customer identification and verification cases escalated from routine onboarding teams. - Manage escalation triage process determining which complex cases require Due Diligence investigation versus resolution at escalations team level. - Champion the adoption of technology and automation solutions within the Onboarding & Due Diligence function, including digital worker deployments, workflow automation tools, and AI-assisted review capabilities. - Oversee the integration of onboarding and due diligence workflows with core banking platforms, risk management systems, and screening and monitoring tools. - Ensure that technology implementations within the function are governed in accordance with MVB's AI Use Governance Framework and Model Risk Management standards. - Set the multi-year technology and automation roadmap for the function, in partnership with Technology and Advisory stakeholders. - Represent the Onboarding & Due Diligence function as the key point of contact during regulatory examinations, internal audits, and external reviews — coordinating information requests, presenting program documentation, and managing feedback and findings to closure. - Ensure the Onboarding & Due Diligence program is examination-ready at all times, with current procedures, complete and well-documented case files, defensible risk ratings, and evidence of consistent application of the risk-based approach. - Lead remediation of audit and examination findings attributable to the Onboarding & Due Diligence function, including root cause analysis, corrective action design, and evidence package development. - Report on function-wide performance, risk, and regulatory posture directly to executive leadership and, as needed, the Board or relevant Board committee. Benefits - Medical, Dental and Vision Insurance - Health Savings Account (HSA), Health Reimbursement Account (HRA) & Flexible Spending Accounts (FSA) - Short- and Long-Term Disability Plan - Group Life Insurance - 401K Salary Deferral Plan - Wellness Program - Education & Tuition Expense Reimbursement - PTO and Unique Vacation Purchase Program - Nationwide Pet Insurance Coverage


