Sr. Director, Global Quality Control

Position Responsibilities

• Lead the company’s global QC function across a fully outsourced model, with end-to-end oversight of external QC laboratories, CMOs, and contract partners supporting clinical and commercial programs.
• Define and execute the global QC strategy, serving as the internal QC subject matter expert across analytical control strategy, compendial compliance, specification lifecycle management, and stability.
• Provide strategic oversight of stability programs, including protocol design, pull schedule governance, data review and trending, shelf-life support, comparability assessments, and post-approval stability commitments.
• Oversee post-approval specification management, including revision strategy, change assessment, comparability impacts, commitment tracking, and implementation through external partners.
• Ensure effective method qualification, validation, transfer, verification, and lifecycle management across outsourced laboratories, including technical troubleshooting and issue escalation.
• Partner with Analytical Development and CMC teams to support method readiness, control strategy development, and phase-appropriate analytical plans for new programs, process changes, and commercialization activities.
• Provide QC leadership for investigations involving OOS, OOT, non-conforming results.
• Establish and monitor quality and operational performance expectations for external testing partners through governance forums, metrics, trend reviews, and business process oversight.
• Author, review, and approve QC-related controlled documents, including specifications, protocols, reports, SOPs, method transfer plans, stability documents, and technical assessments as applicable.
• Build fit-for-purpose QC systems, governance, and internal capabilities appropriate for a virtual biotech environment, with a focus on compliance, technical rigor, and scalability.
• Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global regulators).

Candidate Requirements

• BS/MS degree in a scientific discipline; advanced degree (MS or PhD) preferred
• 15+ years of progressive Quality Control and/or Analytical Sciences experience in biotech/pharma industry (including outsourced operating models), with 7+ years in leadership roles
• Deep technical expertise in analytical methods supporting biologics and/or other advanced therapeutic modalities, including release, stability, and characterization testing.
• Strong working knowledge of USP, EP, and JP pharmacopeial requirements, and cGMP, ICH guidance, global regulatory requirements, and inspection readiness for outsourced QC operations.
• Demonstrated success leading global stability programs, including shelf-life support, data trending, protocol governance, and regulatory commitment execution.
• Proven experience in specification development, justification, and lifecycle management, including post-approval specification revisions and change implementation.
• Extensive experience with method transfer, qualification, validation, verification, and troubleshooting across contract testing laboratories and manufacturing partners. 
• Proven ability to lead through influence in a matrixed organization and manage complex external technical relationships with appropriate rigor and accountability.
• Strong executive presence, sound scientific judgment, and the ability to balance strategic leadership with practical execution.
• Highly proactive, decisive, and capable of independently managing key initiatives.
• Engaged people manager committed to building culture as well as mentorship and talent development