Job Closed

This listing is no longer active.

Loyal logo
Loyal

Healthcare's Leading End-to-End Digital Health Platform

Senior Director, Quality Control, Analytical Development

Location

United States

Posted

42 days ago

Salary

$230K - $280K / year

Seniority

Senior

Postgraduate Degree15 yrs expEnglish

Job Description

Senior Director, Quality Control, Analytical Development

Loyal

• Set and execute the analytical development and QC strategy aligned with Loyal's CMC objectives, resubmission timeline, and PAI readiness • Own the end-to-end analytical and QC lifecycle from early development through commercialization, including method development and validation, commercial QC readiness, product release, stability programs, and post-approval lifecycle management • Author and review analytical sections of regulatory submissions, including CTD modules, NADA/resubmission CMC sections, responses to agency observations, and amendments; this person writes, not just reviews • Lead cross-functional identification and lifecycle management of CQAs, specifications, and control strategies for drug substance and drug product • Lead the development, validation, transfer, and lifecycle management of analytical methods with immediate focus on small molecule OSD, while supporting additional modalities as the pipeline evolves • Own method transfers from development to QC and from internal to contract testing laboratories; ensure methods are robust, transfer-ready, and fit for GMP use • Qualify, manage, and govern contract testing laboratories, including identifying and qualifying alternative testing labs to ensure capability and capacity are not single-source dependent • Ensure contract lab reference standard oversight is governed appropriately, including qualification, traceability, and lifecycle management at external partners • Serve as the accountable leader for GMP analytical and QC operations, ensuring inspection-ready systems and sustained regulatory compliance; own PAI readiness for all analytical and QC activities • Establish and oversee commercial QC operations, including governance of external GMP testing laboratories and service providers • Provide oversight of deviations, investigations, OOS/OOT events, change control, and CAPAs related to analytical and QC activities • Serve as the senior analytical subject matter expert in interactions with FDA CVM and other global animal health regulatory agencies, including regulatory submissions, responses, and inspections • Act as a senior CMC leader on cross-functional program teams, influencing development strategy, timelines, and investment decisions • Build, scale, and lead a high-performing AD and QC organization, including hiring, mentoring, and developing senior technical staff • Own and oversee analytical data systems, ensuring data integrity, 21 CFR Part 11 compliance, and robust digital infrastructure across internal and external partners • Manage resource planning, aligning analytical and QC investments with pipeline priorities and business objectives

Job Requirements

  • Ph.D., M.S., or B.S. in Analytical Chemistry, Chemistry, or a related scientific discipline; advanced degree strongly preferred
  • 15+ years of progressive experience in analytical development and quality control for pharmaceutical products, with deep expertise in small molecule oral solid dosage forms
  • Comfortable being both the strategist and the doer. At Loyal, this person will author CTD sections, qualify labs, and set specifications, not just oversee others doing it
  • Has built and led analytical and/or QC organizations from the ground up, not just maintained inherited infrastructure
  • Demonstrated experience spanning early development, clinical programs, NADA filing, commercial launch, and post-approval lifecycle management
  • Proven track record authoring and reviewing analytical sections of regulatory submissions, including CTD modules, NADA/resubmission CMC sections, agency responses, and amendments
  • Extensive experience with analytical method development, phase-appropriate validation, method transfer to contract testing laboratories, and GMP QC operations
  • Experience qualifying and managing alternative contract testing laboratories to ensure capability and capacity redundancy
  • Strong knowledge of FDA GMP regulations (21 CFR Parts 210/211) and ICH guidelines, with direct experience supporting regulatory submissions and inspections; human health experience is equally valued and CVM-specific nuances can be learned
  • Has led or co-led PAI preparation from an analytical and QC perspective
  • Track record of effective oversight of external GMP testing laboratories and analytical service providers, including governance, performance management, and quality issue resolution
  • Comfortable operating in a lean, resource-constrained environment, builds what is needed, prioritizes well, and does not wait for perfect conditions
  • Strong written communication, able to produce clear, submission-ready analytical documentation.

Benefits

  • Full-coverage health insurance — medical, dental and vision — for you and your dependents
  • $1,000 home office equipment stipend
  • $1,200/year learning budget for books, courses, etc.
  • $250/month wellness budget for gym, cleaners, spa, food, etc.
  • All 3-day weekends are turned into 4-day weekends 🎉
  • Unlimited vacation and paid holidays
  • Paw-ternity leave — adopt a dog and get a day off with your new family member 🐶
  • Competitive salary
  • Company equity options grant for new hires

Related Categories

Related Job Pages

More Director Jobs

Tanium logo

Director of Strategic Accounts

Tanium

Tanium delivers Autonomous Endpoint Management (AEM) with the industry’s only true real-time platform for AI.

Director42 days ago
Full TimeRemoteTeam 1,001-5,000Since 2007H1B Sponsor

• Articulate the value of the Tanium platform to decision makers and expertly manage the complex sales cycle • Nurture and develop relationships within the assigned territory and/or accounts, presenting to the C-suite the value of the Tanium platform • Work with the Partner and Marketing teams to define and support prospecting and sales efforts within assigned territory and/or accounts • Generate appropriate sales development activity to ensure healthy pipeline management • Accurately forecast, maintaining excellent SFDC hygiene • Conduct online webinars or in-person presentations to generate qualified leads • Travel as needed

Switzerland
Cotiviti logo

Director Quality – Payment Integrity

Cotiviti

Founded in 1979, Cotiviti provides analytics-driven payment and network solutions for the healthcare and retail industries, offering services that help payers, risk-bearing healthc

Director42 days ago

• Oversee and drive quality performance across payment integrity solutions, ensuring continuous improvement and operational excellence • Collaborate with cross-functional business units to measure, report, and enhance quality performance metrics and outcomes • Develop and align best-in-class quality processes and standards, delivering exceptional results through operational excellence • Work closely with Operations and Product teams to drive quality improvements by leveraging technology, optimizing processes, and developing talent • Ensure timely and accurate responses for Payment Requests for Information (RFIs) and Request for Proposals (RFPs) • Support client intake requests for PrePayment Business Unit by understanding client requirements and providing tailored solutions and cost estimates • Hire, develop, coach, and retain top-tier talent, fostering a culture dedicated to exceptional quality and customer satisfaction • Optimize labor and operating expenses while increasing productivity, service quality, and supporting future client growth • Lead and support operational improvement initiatives encompassing people, processes, and technology to deliver incremental value and operational efficiency, consistently meeting or exceeding service and quality goals • Enforce Cotiviti’s intellectual property protection best practices throughout all operations • Diagnose and resolve issues proactively, manage schedules, and ensure deadlines are met for timely completion of work • Develop short-term and long-term plans to anticipate client needs and operational improvements • Cultivate a positive workplace culture that supports corporate goals, promotes initiative, and fosters open communication at all organizational levels • Collaborate and support business leaders throughout the organization, maintaining highly effective client and team dynamics in a collaborative environment • Manage and delegate team and individual projects/assignments, and review performance against operating plans and standards • Provide comprehensive reports and metrics to drive operational quality and inform strategic decisions, based on operational objectives and work plans at a senior level • Build, maintain and influence strong relationships with executive leadership to support organizational goals

United States
$140K - $185K / year
Full TimeRemoteTeam 501-1,000

As the leading global type 1 diabetes (T1D) research and advocacy organization, Breakthrough T1D helps make everyday life with T1D better while driving toward cures. We invest in the most promising research to turn ideas into life-changing therapies and devices. We work with government, regulatory officials, and insurance companies to address issues that impact the T1D community -- breaking through barriers that limit access to care worldwide. We provide resources and guidance that makes it easier to live and thrive with T1D. This is more than a moment -- we're empowering a movement for the T1D community. Share your support and help educate and empower individuals facing type 1 diabetes. Our mission is to improve lives today and tomorrow by accelerating life changing breakthroughs to treat, prevent and ultimately, cure T1D and its complications. Always, we are guided by a single purpose: As we drive towards curing type 1 diabetes, we help make everyday life better for the people who face it. The Chapter Director (CD) supports the organizational strategies and mission by serving as the chapter’s primary external affairs officer while building strategic relationships with constituents and donors on behalf of Breakthrough T1D, expanding our reach to support maximum chapter and market penetration. The CD ensures increased efficiency, effectively utilizing core program metrics and key indicators to drive year-over-year trends, goal attainment and maximum performance impact. The CD develops and sustains effective volunteer board in assigned market and leads relationship building with key donors and volunteers. The CD collaborates with Global Development on activities to generate greater revenue and volunteer impact. This individual is a visionary and motivator who effectively brings the mission to life within the community through collaboration, cultivation, inspiration, and engagement. Utilizing exceptional time management skills, they proficiently execute activities that support organizational strategies in the assigned chapter to drive optimal results and actively demonstrate and promote enterprise-wide mindsets. As one of the top performing territories in the country, the Southern States Territory includes Alabama, Arkansas, Louisiana, Mississippi and Tennessee, and plays a vital role in the organization’s success. The territory has 16 staff, 7 Boards, 17+ events, and collectively drives approximately $7 million in total net revenue. The LA Chapter Director is responsible for fundraising in the LA Chapter with events across the state including Baton Rouge and New Orleans. Collaboration with staff, committee members, volunteers, and managing a 15+member LA Chapter local board to raise $800,000 annually through BT1D signature events, including a Gala and P2P campaigns. This is a remote position; however, the ideal candidate is required to reside in Baton Rouge or New Orleans, LA areas. Key Responsibilities Fundraising & Engagement – 50% - Execute strategic revenue plans to drive profitable, diversified, and sustainable year-over-year growth in the chapter. - Assume responsibility for achieving both personal and chapter level revenue goals; and support the achievement of territory revenue goals. - Drives new levels of performance in Peer 2 Peer, Signature Events, individual giving, and constituent relationship management within the chapter. - In collaboration with national and chapter partners, collaborate on annual strategy for corporate engagement, major giving, and stewardship at the chapter level. Identify and develop new business with existing donors and new prospects. Volunteer Management – 25% - Engage and leverage the Community Board in assigned chapter area and ensure the on-going development of a strong and impactful board. - Guide the board nominating process and provide direct support and leadership in attracting and retaining high-impact board members and ensure it represents the community served. - Ensure meaningful engagement of volunteers at all levels and promote good working relationships between staff and volunteer leadership. - Partner with volunteer leadership to solicit funding and other support from individuals, corporations, foundations and other sources of funding and/or influence. Awareness – 15% - Provide leadership for the cultivation of productive relationships with constituents, media, and health care partners to advance brand awareness and mission priorities. - Promote mission engagement opportunities throughout the community in the areas of research, advocacy, and clinical trials. - Support active and growing Community Engagement programs to acquire and activate new families. - Collaborate with territory staff on the engagement of mission-focused volunteer leadership – including Advocacy Team Chairs, Clinical Trial Education Volunteers, and Mission Information Volunteers – to advance the priorities of the organization. Administration and Management – 10% - Provide leadership, performance management and professional staff development and build a strong, cohesive, and collaborative team. - Accountable for the development, management, and attainment of annual budgets, the maintenance of fiscal records, and the timely and accurate submission of Breakthrough T1D financial and forecast reports. - Ensure staff and volunteers adhere to organizational policies and procedures, including annual training and other compliance requirements. - Represent the interests, professionalism, and integrity of Breakthrough T1D in all activities and relationships through a unified message of the Breakthrough T1D mission, and a commitment to organizational standards and leadership by personal example. - Serve as an active member of the Territory Executive Team providing overall leadership, mentoring, and operational direction to ensure cost-effective and efficient systems. Requirements: - 7-10 years of professional fundraising experience, with a clear record of achievement in a complex, mission-driven organization; 5-7 years in a supervisory capacity. College degree or equivalent combination of education and experience. - Record of success in a fundraising leadership role, with revenue responsibilities in excess of $2M; experience working directly or leading staff teams particularly in large scale events (walk, gala, etc.) and major and corporate giving. Strong skills in the identification, cultivation, solicitation, and on-going stewardship of donors and supporters - Experience in partnering with strong and active volunteer leaders, including working successfully with a large network of passionate volunteers. - High degree of energy, integrity, courage, empathy, and creativity. High emotional IQ. Superior active listening, analytical, and critical thinking skills. - Demonstrates the ability to inspire, lead, and motivate teams while fostering an inclusive and respectful work environment through all interactions with staff and volunteers. Exhibits effective delegation skills to enhance both organizational and individual productivity. - Ability to develop and successfully maintain an extensive network of strategic relationships (donors, volunteers, community partners, etc.) in the local area. Existing knowledge and network of relationships in the territory preferred. - Ability to be an enthusiastic spokesperson/representative of Breakthrough T1D’s mission. High level of comfort communicating complex information (e.g., Breakthrough T1D research, goals, etc.) to a wide range of audiences so that they can understand and retain the content. - History of effective performance management that aligns staff efforts with organizational goals. - Proficiency in Salesforce CRM and MS Suite, essential for managing donor relationships and streamlining operations. - Highly efficient in time management and able to meet deadlines under pressure. Ability to travel locally required. Occasional overnight travel as needed. Essential Functions: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools or controls. The employee is occasionally required to stand, walk, sit, reach with hands and arms, climb or balance, and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 25 pounds, and infrequently up to 50 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, and the ability to adjust focus. The noise level in the work environment is usually moderate. Benefits: Breakthrough T1D offers competitive benefits, including medical, dental, and vision coverage, a 403(b) retirement plan, voluntary benefits, flexible spending and commuter benefit accounts, an employee assistance program (EAP), life and disability insurance, performance-based bonuses, and generous paid time off. Benefits may vary by job level and full time or part time status. Additional information: Requests for medical, religious, and other exemptions will be considered on an individual basis. Breakthrough T1D will comply with all federal, state, and local laws. Breakthrough T1D supports a diverse and inclusive workforce. Breakthrough T1D is an Equal Opportunity Employer. All your information will be kept confidential according to EEO guidelines.

Louisiana
ICF logo

Senior Archaeologist

ICF

Founded in 1969, ICF is a global advisory and technology services company headquartered in Reston, Virginia. It delivers data-driven solutions across energy, environment, infrastru

Director42 days ago

Description ICF seeks an experienced Senior Archaeologist for our Northern California region with a focus on the Sacramento/San Joaquin Central Valley.  This position is intended to be based in the Sacramento, CA office, however it can be fully or partially remote, and applicants living throughout northern CA are encouraged to apply. The Senior Archaeologist should be comfortable working across the primary disciplines that comprise cultural resources management (archaeology, built environment, tribal resources, landscapes) and comfortably navigate between project management (scoping, staffing, progress reporting) and delivery of technical services (quality control, schedule, cost). This position includes performing historical research, fieldwork, and report writing for archaeology studies and developing and implementing regulatory compliance solutions in support of our clients’ compliance with the California Environmental Quality Act (CEQA), the National Environmental Policy Act (NEPA), and the National Historic Preservation Act (NHPA). Projects are anticipated to focus on Transportation, Water, Energy, and Planning & Development clients. At ICF, you will work with talented and passionate individuals and will grow with a firm that believes in nurturing talent to develop long-term career success. Our cultural resources team includes experts in architectural history, history, archaeology, GIS, data management, environmental regulations, and planning.   Why you will love working here:  - Quality of life: Flexible workplace arrangements, work-life balance   - Investment of the community: Donation matching, volunteer opportunities  - Investment in you: Tuition reimbursement, access to professional development resources, 401k matching, Employee Stock Purchase Plan   - And many, many more (Ask your recruiter for more details!)  What you will be doing:  - Work on projects related to environmental compliance and cultural resource management, including client contact, task order management, budget control, invoicing, schedule, personnel allocation/planning, and subcontractor involvement  - Lead or participate in investigations that identify and evaluate resources for National Register of Historic Places and/or the California Register of Historical Resources, assess project effects on resources, develop resource management recommendations, and provide support to address complex management challenges that require a command of technical and regulatory knowledge - Collaborate in integrated teams of cultural resources specialists (archaeologists, historians, ethnographers, landscape historians, etc) to solve problems alongside natural resources scientists, planners, regulators, engineers, and other stakeholders  - Support clients to achieve long-term objectives and efficiencies, from programmatic strategies and feasibility studies through implementation, operations, and maintenance  What You Will Need To Have (Minimum Qualifications):   - Master’s degree in Anthropology, Archaeology or related field.  - 7+ years of professional experience in cultural resources management.  - Experience obtaining concurrence NHPA Section 106 findings and serving as archaeology lead for the full cycle of CEQA review including meeting requirements for consideration of Tribal cultural resources (a.k.a. AB 52). - Registered Professional Archaeologist certification. What We’d Like You to Have (Preferred Qualifications):    - Thorough knowledge of CEQA, NEPA and Section 106 regulatory requirements  - Advanced knowledge northern California native American tribes and regional contexts. - Strong fieldwork skills including pedestrian and subsurface survey, testing and evaluation, and a working knowledge of GPS. - Qualifications and experience to be BLM-permitted as a Principal Investigator in California and Nevada. - A background working with private and public sector clients and regulatory agencies. Professional skills you will use:  - A desire to participate in and contribute to a progressive work environment for employee development and career fulfillment  - A desire to excel and passion for rewarding work on complex environmental challenges in a team environment  - Excellent interpersonal skills and empathy  - Demonstrated ability to think strategically  - Ability to work effectively as part of a team in a multi-disciplinary environment  - Orientation toward fulfilling client objectives  Working at ICF ICF is a global advisory and technology services provider, but we’re not your typical consultants. We combine unmatched expertise with cutting-edge technology to help clients solve their most complex challenges, navigate change, and shape the future. We can only solve the world's toughest challenges by building a workplace that allows everyone to thrive. We are an equal opportunity employer. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO policy. We will consider for employment qualified applicants with arrest and conviction records. Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation, please email Candidateaccommodation@icf.com and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations.  Read more about workplace discrimination rights or our benefit offerings which are included in the Transparency in (Benefits) Coverage Act. Candidate AI Usage Policy At ICF, we are committed to ensuring a fair interview process for all candidates based on their own skills and knowledge. As part of this commitment, the use of artificial intelligence (AI) tools to generate or assist with responses during interviews (whether in-person or virtual) is not permitted. This policy is in place to maintain the integrity and authenticity of the interview process.  However, we understand that some candidates may require accommodation that involves the use of AI. If such an accommodation is needed, candidates are instructed to contact us in advance at candidateaccommodation@icf.com. We are dedicated to providing the necessary support to ensure that all candidates have an equal opportunity to succeed.   Pay Range - There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position based on full-time employment is: $73,770.00 - $125,408.00 California Remote Office (CA99)

United States
$73.8K - $125K / year