Executive Director, Quality Assurance
About The Position
The Global Quality Group within the Manufacturing Division is seeking an experienced Leader to provide strategic oversight and direction for a complex, enterprise-level transformation program. This project aims to transform QC testing to support our pipeline and in-line supply products. The project has significant innovation components including end-to-end analytical digitization, analytical instrumentation innovation, lab automation, standardized laboratory workflows, and a digitized QMS and lab operations system. The Quality Lead, in collaboration with the project leadership team, will oversee integrated planning, governance, and execution across a highly matrixed project, ensuring alignment to GxP requirements while incorporating novel technical and digital laboratory components and delivery of key program outcomes. They will partner with executive leadership, business stakeholders, cross-functional teams and external partners, as necessary, to manage interdependencies, support timely decision-making, and advance the program from project planning to regulatory filing and approval and through operational transition and sustainment. They will be a key input to an integrated plan that includes Technology Development, Analytical Development, Quality and Compliance, Regulatory, IT and external partners all collaborating seamlessly to deliver a scalable, compliant, and future-ready model, all within an aggressive timeline.
Requirements
- Bachelor’s degree required
- 15+ years of relevant experience in quality, pharmaceutical development, manufacturing and science technical operations, or related biopharmaceutical functions.
- Leadership experience with CGMP testing laboratories subject to FDA inspections.
- Demonstrated experience utilizing an innovative mindset to challenge the status quo and improve workflows.
- Experience in development and implementation of laboratory technology.
- Experience in GxP, quality, and compliance-driven management programs.
- Strong program governance, structured execution, and analytical skills.
- Excellent communication, stakeholder management, and executive presentation skills.
- Proven experience leading enterprise-level technology transformation or lab innovation programs
- Ability to manage multiple priorities and complex interdependencies effectively.
- Strong understanding of regulated, scientific, technical, or IT/program environments.
- Financial acumen, including budgeting, forecasting, and value tracking.
- Proven ability to build alignment across internal and external cross-functional teams.
Nice To Haves
- Advanced degree (PhD, MBA, PharmD, or equivalent) strongly preferred
- Programming experience will be an asset.
- Experience in research and development within the pharmaceutical industry and in clinical phase Quality expectations.
- Experience supporting workforce strategy, technology evaluation, or enterprise transition initiatives.
- Experience working directly with third party technology providers.
- Experience with filing and registering new products.
- Experience with stage gate or capital governance models.
Responsibilities
- Provide strategic oversight and direction for a complex, enterprise-level transformation program.
- Oversee integrated planning, governance, and execution across a highly matrixed project.
- Ensure alignment to GxP requirements while incorporating novel technical and digital laboratory components and delivery of key program outcomes.
- Partner with executive leadership, business stakeholders, cross-functional teams and external partners to manage interdependencies, support timely decision-making, and advance the program.
- Direct decision forums that enable alignment and remove barriers.
- Proactively manage risks, assumptions, constraints, and interdependencies across highly matrixed, cross-functional teams.
- Provide clear, data-driven insights and recommendations.
- Drive technology and operating model transformation.
- Ensure alignment with quality and regulatory requirements.
- Enable adoption and transition outcomes into sustainable operations.
- Supervise Quality and other personnel in direct support of the cross-functional program goals.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Executive
