AVP, External Quality

About this role

Job Description

The Head of External Manufacturing Quality – Large Molecule leads our Manufacturing Division's global External Manufacturing Quality organization for biologics and vaccines.

This leader directs a multinational team of approximately 100 professionals and establishes the quality strategy, governance, and oversight model for products manufactured, tested, packaged, released, stored, and distributed through our company's external manufacturing network.

The role ensures compliance with our company's requirements, applicable regulatory expectations, and global GMP standards while enabling reliable supply, supporting timely product launches, and strengthening the execution of technology transfers across approximately 30 external manufacturing sites spanning cell banking, drug substance, and drug product operations.

This role sets the direction for a global External Manufacturing Quality organization that protects product quality, patient safety, and regulatory compliance while enabling business continuity and supply reliability. The position serves as a senior quality leader across our company's biologics and vaccines networks, driving consistent standards, strong partner oversight, and effective governance that support launch readiness, lifecycle execution, and operational excellence across the external manufacturing network. The role reports to the Vice President of Quality, Global Biologics.

Primary Responsibilities: • Lead the strategy, organizational design, budget oversight, and performance management for a global External Manufacturing Quality team of approximately 100 professionals.

• Establish and maintain a risk-based quality oversight framework for approximately 30 external manufacturing sites supporting cell banking, drug substance, drug product, packaging, testing, release, storage, and distribution.

• Direct quality oversight of external manufacturing partners to ensure products are manufactured, tested, packaged, and released in accordance with our company's requirements and global regulatory expectations.

• Drive timely product release, or coordination of release, for external supplier-manufactured materials to support supply continuity and customer demand.

• Lead major External Manufacturing Quality investigations, including fact finding, root cause assessment, regulatory notifications, and recall coordination when required.

• Provide quality leadership for technology transfers, product launches, pre-approval inspections, and other critical supply and regulatory milestones.

• Strengthen partner readiness by providing strategic quality support, technical guidance, and direct engagement with external partner leadership teams.

• Review audit and inspection outcomes for external manufacturers and ensure effective corrective and preventive actions are defined, implemented, and sustained.

• Oversee complaint review and quality issue escalation processes for products manufactured through the external network.

• Define clear performance expectations, metrics, and governance routines to monitor and improve quality and operational performance across external partners.

• Chair periodic quality performance reviews with external manufacturing partners to drive accountability, transparency, and continuous improvement.

• Lead due diligence assessments for prospective external partners and ensure identified gaps are addressed through appropriate remediation and oversight.

• Establish and maintain Quality Agreements and provide expert consultation on commercial agreements as needed to protect our company's quality and compliance requirements.

• Build effective quality systems at partner sites through calibrated oversight, continuous improvement initiatives, and targeted support aligned to risk and performance.

• Establish and chair the External Manufacturing Quality Council and communicate key quality, compliance, and business risks to senior leadership forums.

• Serve as a member of the Biologics Quality Leadership Team and External Manufacturing Leadership Team, with dotted-line partnership to the Vaccines Quality Leadership Team and other relevant governance bodies.

• Promote a culture of accountability, collaboration, operational excellence, and proactive problem-solving across the internal organization and external partner network.

Education: • Bachelor’s degree in a scientific discipline required

• Advanced degree preferred

Required Experience and Skills: • Minimum of 10 years of experience in Quality Systems, Quality Assurance, and/or Quality Control within pharmaceutical manufacturing operations under global GMP and health authority requirements.

• Demonstrated experience leading quality oversight of third-party manufacturers in a regulated environment, ideally within FDA/cGMP and global regulatory settings.

• Proven track record managing complex quality investigations, assessing risk, and making timely, data-driven decisions.

• Strong compliance background with experience supporting regulatory inspections and health authority interactions.

• Significant experience across quality operations, including quality laboratories, batch release, quality assurance, and quality systems.

• Demonstrated success leading and developing large, global, matrixed teams.

• Experience with biologics and vaccines manufacturing across multiple nodes, including drug substance, drug product, packaging, and laboratories.

• Experience supporting technology transfers, product launches, pre-approval inspections, and facility start-up activities.

• Ability to travel approximately 30% of the time, including occasional short-notice travel.

Preferred Technical/ Functional Skills: • Advanced degree in a relevant scientific or technical field.

• Experience leading global external manufacturing quality networks across both biologics and vaccines.

• Prior leadership of a large multinational quality organization with direct accountability for partner performance, complianc

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