Vice President, Quality Control

Key Interfaces

Key Responsibilities

• Establish and lead the global Quality Control strategy, including laboratory infrastructure, testing frameworks, and lifecycle management across development and commercial programs.
• Provide governance and oversight for QC systems including specifications, test methods, environmental monitoring, stability programs, reference standards, and batch release support.
• Ensure QC activities are compliant with global regulatory requirements (FDA, EMA, ICH) including cGMP expectations and data integrity standards.
• Lead method qualification, validation, transfer, and performance monitoring in partnership with Analytical Development.
• Oversee internal and external laboratory operations, including CROs and CDMOs.
• Drive QC support for manufacturing operations including in-process, release, and stability testing.
• Provide leadership for OOS/OOT investigations, deviations, and CAPA implementation.
• Support regulatory submissions and inspections in collaboration with QA and Regulatory Affairs.
• Advance QC through digital transformation, automation, and laboratory systems (LIMS, ELN).
• Build and lead a high-performing QC organization.
• Manage budgets, capital planning, and resources aligned to program priorities.

Required Qualifications

• Advanced degree in a scientific discipline preferred or equivalent experience.
• 15+ years of experience in Quality Control in the biopharmaceutical industry.
• Experience supporting biologics, viral vector, or advanced therapy products.
• Strong knowledge of QC systems including validation, microbiology, stability, and data integrity.
• Experience with global regulatory submissions and inspections.
• Proven leadership and team management capabilities.

Preferred Qualifications

• Experience building or transforming QC organizations.
• Experience with advanced therapy modalities (gene therapy, viral vectors).
• Experience implementing digital QC systems.
• Experience managing external laboratory networks.
• Industry leadership through publications or regulatory engagement.

Leadership Competencies

• Strategic leadership with strong quality and regulatory expertise.
• Ability to influence cross-functional teams.
• Strong risk-based decision making.
• Commitment to quality culture and inspection readiness.
• Excellent communication skills.

Must be authorized to work in US. We cannot provide sponsorships.