Executive Director, Quality Assurance

Job Description

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.

Key Responsibilities and Requirements

The ideal candidate can meld strong technical skills and an innovation mindset to set strategic Quality direction and compliantly translate it into an integrated end-to-end program plan while managing and executing that plan across milestones dependencies and the critical path. This role is responsible for directing decision forums that enable alignment and remove barriers while proactively managing risks assumptions constraints and interdependencies across highly matrixed cross-functional teams. Acting as the connective link between executive sponsors and delivery teams the candidate provides clear data-driven insights and recommendations drives technology and operating model transformation and ensures alignment with quality and regulatory requirements. Success in this role requires a structured analytical leader with strong stakeholder and communication skills an innovation mindset a focus on measurable value realization and the ability to enable adoption and transition outcomes into sustainable operations. A strong background in analytical development analytical testing and automation validation within a GMP laboratory is expected. The role will also need to have expert level leadership to supervise Quality and other personnel in direct support of the cross-functional program goals.

Required Experience

Bachelors degree required; advanced degree (PhD MBA PharmD or equivalent) strongly preferred with

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.

Preferred Experience

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.

Required Skills:

Ability to Coordinate Ability to Coordinate Analytical Thinking Aseptic Manufacturing Competency Management Conflict Resolution Cross-Cultural Awareness Cross-Functional Project Management Customer-Focused Detail-Oriented Driving Continuous Improvement Financial Acumen Innovation Management Leadership Project Management Legal Compliance Microbiology Organizational Change Management People Leadership Performance Plans Process Alignment Process Innovation Product Lining Project Integration Project Management Leadership Project Planning 9 more

Preferred Skills:

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The salary range for this role is

$210400.00 - $331100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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Employee Status:

Regular

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Flexible Work Arrangements:

Hybrid

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Job Posting End Date:

10/5/2026

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