Job Closed

This listing is no longer active.

eClinical Solutions logo
eClinical Solutions

We bring people and data together to support tomorrow’s breakthroughs

Manager, Quality Systems – Operations

OperationsOperationsFull TimeRemoteSeniorTeam 201-500Since 2012H1B SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

18 days ago

Salary

$120K - $150K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Manager, Quality Systems – Operations

eClinical Solutions

• The Manager, QSO will oversee core quality system processes including document control, SOP lifecycle management, training administration and effectiveness support, quality events and CAPA management, quality metrics and management reporting, and cross-functional process improvement initiatives. • Serve as operational lead for daily quality system workflows, requests, escalations, and prioritization. • Ensure timely execution of quality deliverables including document approvals, event reviews, CAPA follow-up, training assignments, and management reporting. • Coordinate core quality activities across business and technical functions in a fast-paced SaaS / vendor setting. • Oversee quality events including deviations, incidents, customer quality issues, audit observations, system/process nonconformances, and supplier quality concerns as applicable. • Manage CAPA lifecycle from initiation through closure, including root cause analysis, action tracking, due dates, evidence review, and effectiveness verification. • Support administration of the quality training program and learning compliance processes. • Develop and maintain enterprise quality dashboards, KPIs, and trend reports. • Report on QMS health including document control cycle times, CAPA status, training compliance, audit observations, quality events, and recurring risks. • Identify opportunities to streamline, automate, and mature quality processes while maintaining compliance. • Lead initiatives to improve user experience and adoption of quality systems/tools. • Partner with Product, Engineering, DevOps, Security, and Operations teams to embed practical quality controls into business processes.

Job Requirements

  • Bachelor’s degree in Life Sciences, Quality, Engineering, Computer Science, Business, or related discipline preferred
  • 5+ years of experience in Quality Systems, Quality Operations, Compliance, or related roles within a regulated environment preferred
  • Experience in a clinical trial software vendor, SaaS healthcare technology, CRO, life sciences technology, eClinical, or related GxP-supporting organization
  • ASQ, Six Sigma, ISO, GxP, or related certifications preferred
  • Working knowledge of GxP principles, computerized systems controls, data integrity expectations, and risk-based quality management
  • Experience supporting customer audits, supplier audits, or regulatory inspections preferred
  • Experience managing CAPA, investigations, document control, training systems, and quality metrics
  • Strong communication, organization, and stakeholder management skills
  • Familiarity with CSV / CSA concepts and validation documentation for regulated systems preferred
  • Experience using electronic QMS platforms and workflow systems
  • Experience with tools such as Qualio, Veeva, MasterControl, TrackWise, Jira, or similar platforms preferred

Benefits

  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options

Related Categories

Related Job Pages

More Operations Jobs

Role Description A global advisory and consulting organization is seeking a senior-level Business Operations consulting lead to support complex sourcing and operational transformation engagements. This role focuses heavily on business process outsourcing strategy, operational improvement initiatives, and large-scale sourcing advisory work across finance, procurement, shared services, and related business functions. The Principal Consultant will lead client engagements from strategy through execution, working closely with executive stakeholders to: - Assess current operations - Develop recommendations - Manage delivery - Drive successful outcomes This person will also play a role in identifying additional client opportunities and supporting broader business development efforts. This is a contract opportunity with potential for future full-time consideration. Additional Details: - Remote position with approximately 25–50% travel - Candidates must currently reside in Canada - Independent contractors are welcome - No third-party vendors or agencies please Qualifications - 5–15 years of experience across business operations consulting, outsourcing advisory, shared services, finance/accounting operations, procurement, or related transformation environments - Strong understanding of sourcing models, outsourcing agreements, service delivery structures, and operational optimization - Experience working within or alongside large consulting firms, advisory organizations, or outsourcing providers is highly valued - Ability to lead executive-level conversations and translate complex operational issues into practical business recommendations - Strong financial acumen, including budgeting, process cost analysis, and business case development - Experience managing complex consulting engagements and cross-functional delivery teams - Knowledge of sourcing contracts, SLAs, vendor management, and proposal development - Strong presentation and communication skills with executive audiences - PMP certification and prior consulting delivery leadership experience are considered strong pluses Requirements - Lead large, complex consulting engagements focused on business operations, sourcing strategy, and operational transformation - Advise clients on shared services, global business services (GBS/GCC), outsourcing models, and hybrid delivery structures - Help clients evaluate and optimize service delivery, operational efficiency, and vendor relationships - Build and manage detailed financial models, budgets, business cases, and operational analyses - Support RFP development, statement of work creation, SLA definition, and sourcing contract negotiations - Evaluate outsourcing provider proposals and guide clients toward the best-fit solutions - Develop sourcing and negotiation strategies that align with client objectives - Partner directly with senior client executives and service provider leadership teams - Manage project scope, timelines, staffing, risk, reporting, and overall delivery quality - Contribute to sales pursuits, intellectual property development, and internal consulting initiatives - Bring practical understanding of AI and Agentic AI applications within business process environments Education - Bachelor's degree required - MBA or advanced degree preferred

Canada
Job Closed
Arbi Arredobagno logo

Delivery Operations Manager

Arbi Arredobagno

The perfect design for every bathroom

Operations18 days ago
Full TimeRemoteTeam 51-200Since 1987H1B No Sponsor

• Lead and manage a team of Delivery Operations Analysts, including hiring, performance management, development, and daily coaching. • Own team KPIs including on-time go-live rates, time-to-resolution, implementation cycle times, and client satisfaction scores. • Build and maintain operational cadence — weekly standups, sprint reviews, stakeholder reporting, and escalation management. • Identify bottlenecks and process gaps across the delivery lifecycle and implement scalable fixes. • Serve as the escalation point for high-priority or at-risk client accounts. • Serve as the operational lead for onboarding newly acquired companies into the organization's systems, processes, and culture. • Design and execute integration playbooks covering tools, workflows, reporting structures, and team harmonization. • Partner with cross-functional teams (Finance, IT, HR, Legal, Business Units) to manage change across acquired entities. • Lead stakeholder workshops and training sessions to align acquired teams to current operating standards. • Track integration milestones, risks, and dependencies — reporting progress to senior leadership throughout the transition. • Build and maintain governance frameworks for project delivery, including SOPs, templates, RACI models, and escalation protocols. • Apply professional services and business consulting project lifecycle to standardize delivery methodology across the team and client base. • Drive continuous improvement initiatives around people and processes. • Develop and maintain a centralized project management infrastructure to ensure delivery visibility across all active accounts. • Oversee team usage of JIRA, Salesforce, and Microsoft Dynamics 365 (D365) — ensuring data accuracy, process compliance, and cross-system consistency. • Build and maintain operational dashboards and reporting frameworks using Power BI or equivalent tools. • Define and enforce data governance practices across delivery tools to eliminate duplication and ensure real-time accuracy.

Canada
$75K - $100K / year
Job Closed
Full TimeRemoteTeam 501-1,000H1B No Sponsor

• Enable commercial strategy execution across Precision AQ through data, insights, and operational rigor • Own sales forecasting and pipeline governance, ensuring high levels of accuracy, quality, and forward‑looking visibility • Develop and evolve executive‑level dashboards and reporting that clearly communicate performance trends, risks, and opportunities • Drive commercial initiatives (e.g., Go-to-Market motion scale, pipeline hygiene composite score baseline) and insights forward, shaping leadership discussions and decision‑making • Partner with Business Group and Practice Area leaders to support go‑to‑market planning, account planning, performance tracking, and operational alignment • Lead continuous improvement of sales processes, operating rhythms, and productivity • Evaluate, select, and implement sales operations enabling technologies, including Salesforce enhancements, plugins, automation tools, and GenAI capabilities • Serve as the commercial business owner for Salesforce, ensuring strong data governance, usability, and adoption • Identify blockers to growth and mobilize cross‑functional solutions to improve commercial effectiveness

United States
$147K - $220K / year
Precision Medicine Group logo

Director, Sales Operations

Precision Medicine Group

Precision Medicine Group delivers specialty services that help its life science clients navigate healthcare challenges. The company entered its 10th year of suc

Operations18 days ago

• Enable commercial strategy execution across Precision AQ through data, insights, and operational rigor • Own sales forecasting and pipeline governance, ensuring high levels of accuracy, quality, and forward‑looking visibility • Develop and evolve executive‑level dashboards and reporting that clearly communicate performance trends, risks, and opportunities • Drive commercial initiatives (e.g., Go-to-Market motion scale, pipeline hygiene composite score baseline) and insights forward, shaping leadership discussions and decision‑making • Partner with Business Group and Practice Area leaders to support go‑to‑market planning, account planning, performance tracking, and operational alignment • Lead continuous improvement of sales processes, operating rhythms, and productivity • Evaluate, select, and implement sales operations enabling technologies, including Salesforce enhancements, plugins, automation tools, and GenAI capabilities • Serve as the commercial business owner for Salesforce, ensuring strong data governance, usability, and adoption • Identify blockers to growth and mobilize cross‑functional solutions to improve commercial effectiveness

United States
$147K - $220K / year