Vice President Quality Assurance

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.
• 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 Operationsmanufacturing quality.
• 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.

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 increasing levels of responsibility, with substantial experience in clinical/GCP quality.
• Minimum of 5 years of hands-on experience in one or more of the following partner disciplines before transferring into a QA role: Clinical Trial Management, Clinical Operations, Chemical/Drug Product Development or Manufacturing, Analytical Development.
• Demonstrated success in building and leading a clinical quality organization capable of supporting a clinical/early commercial small pharmaceutical company.
• Demonstrated success in supporting programs from clinical development through commercial readiness and lifecycle management.
• Mastery of global GxP requirements, with deep expertise in GCP (ICH E6, FDA, EMA) and working knowledge of GCLP, GPV, cGMPs, and applicable international regulations and guidelines.
• Expertise overseeing quality aspects of global vendor networks, particularly CROs and clinical sites, and pharmacovigilance vendors; working knowledge of CMO/CDMO oversight.
• Expertise authoring and reviewing clinical SOPs, deviations, CAPAs, investigations, and change controls.
• Expertise performing and managing GCP-focused Quality audits and Health Authority inspections (e.g., BIMO, EMA GCP inspections).
• Demonstrated understanding of issue management, risk management, and CAPA effectiveness in clinical trial environments.
• Experience with batch review and release for clinical phase products.
• Strong collaboration skills and sufficient technical acumen to enable effective cross-functional partnering with Clinical Operations, Regulatory, Technical Operations, and other key stakeholders.
• Excellent written and verbal communication skills with strong executive presence and influencing capabilities.
• Ability to manage competing priorities and timelines in a fast-paced, evolving environment.
• Strong problem-solving skills and ability to implement scalable Quality Systems improvements.
• Demonstrated commitment to quality, compliance, patient safety, and data integrity.
• Working knowledge of oncology drug development.