Executive Director, Quality Assurance

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.

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.

• Bachelor's 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…