Vice President Quality Assurance

The Head of Quality Assurance is responsible for providing strategic and operational quality assurance oversight for clinical operations, clinical development, pharmacovigilance, and manufacturing and external partner activities across all phases of drug development, product launch, and commercialization.

This individual will lead the continued development, implementation, and maintenance of scalable, phase-appropriate Quality systems and governance frameworks to support clinical development, inspection readiness, commercialization activities, and commercial product lifecycle management, with particular emphasis on GCP compliance and clinical trial quality oversight.

The Head of Quality will work cross-functionally with Regulatory, Clinical Operations, Clinical Development, Pharmacovigilance, and Technical Operations as well as external CROs, clinical sites, CMO/CDMOs, and PV partners, to ensure compliance with applicable global regulations and to maintain a strong culture of quality, integrity, patient safety, and data integrity.

Responsibilities

• Build, lead, and manage a quality assurance team capable of supporting the company's growing global clinical and technical development activities throughout the development continuum, including commercialization and lifecycle management.
• Provide strategic and operational oversight of the company's Quality Assurance operation, with primary focus on clinical quality and GCP compliance.
• Ensure Quality approaches appropriately support execution of clinical trials, including oversight of CROs and GCP compliance activities.
• Plan, conduct, and complete reports for clinical site, CRO, and PV vendor audits; oversee CMO/CDMO audits as needed.
• Lead external Health Authority inspections, internal audits, and inspection readiness activities with particular depth in GCP, supported by GPV and GMP functions.
• Continue to develop and maintain the company's clinical Quality Management Systems in a phase-appropriate manner, ensuring adherence to applicable global regulatory requirements (FDA, EMA, ICH E6(R2/R3), and other relevant GCP guidance) and industry standards.
• Author, review, and revise clinical quality SOPs, policies, and controlled quality documentation.
• Define and drive a pragmatic, data-driven, phase-appropriate clinical Quality strategy aligned with company objectives and development milestones.
• Establish governance frameworks, escalation pathways, and quality metrics to enable proactive risk management and informed decision-making across clinical programs.
• Provide Quality oversight of external CRO, clinical site, and PV vendor networks; provide Quality oversight of manufacturing, laboratory, packaging, labeling, and distribution partners as needed.
• Oversee pharmacovigilance quality activities and vendor oversight to ensure compliance, data integrity, and effective safety surveillance.
• Ensure effective oversight and timely resolution of clinical quality issues, deviations, investigations, CAPAs, change controls, and product complaints, including protocol deviations, informed consent issues, and site-level findings, seeking input from relevant departments to ensure fully informed evaluations of quality impact.
• Review and approve clinical protocols, informed consent forms, and clinical quality aspects of IMPD/IND submissions.
• Review and approve clinical product labels.
• Responsible for final release or other disposition of clinical trial material, including country-specific release requirements and collaboration with Qualified Persons (QPs), in partnership with Technical Operations manufacturing quality.
• Provide Quality input into manufacturing scale-up and validation strategies as they intersect with clinical supply, and commercial readiness initiatives.
• Oversee batch record review (Executed and Master) and analytical documentation as needed to support clinical trial material release.
• Drive consistency in quality processes, risk management approaches, and data integrity standards across the organization.
• Keep current with global health authority laws and regulations, particularly GCP-related; identify gaps and implement process improvements resulting from new or revised regulations or guidance.
• Participate in project teams and sub-teams as needed.

Required Qualifications

• BA/BS in Science, Engineering, or related discipline required; advanced degree (MS, PhD, PharmD, or equivalent) preferred.
• Minimum of 10+ years of Quality Assurance experience in an FDA-regulated Biotech or Pharmaceutical environment with…