Senior Director, Quality Compliance

Responsibilities

• Develop and implement a comprehensive, risk-based quality compliance strategy aligned with global regulatory expectations (FDA, EMA, MHRA, ICH).
• Provide executive oversight of core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.
• Serve as a senior quality advisor to executive leadership on compliance risks, trends, and mitigation strategies.
• Establish and maintain a robust global supplier quality management program for CMOs, CROs, and critical vendors.
• Oversee qualification, auditing, performance monitoring, and ongoing compliance of external partners.
• Lead development and negotiation of quality agreements to clearly define roles, responsibilities, and compliance expectations.
• Drive vendor performance management through KPIs, risk assessments, and governance forums.
• Provide strategic oversight of the global product quality complaint program, ensuring timely investigation, trending, and closure.
• Ensure compliance with regulatory reporting requirements, including Field Alert Reports (FARs), Biological Product Deviation Reports (BPDRs), and other post-market obligations.
• Drive continuous improvement in complaint handling processes, including root cause analysis and CAPA effectiveness.
• Partner with manufacturing, supply chain, and regulatory teams to mitigate product quality risks and prevent recurrence.
• Lead global inspection readiness strategy, ensuring a continuous state of readiness across all GxP areas.
• Serve as inspection lead and primary point of contact for regulatory agency inspections (FDA, EMA, MHRA, and other health authorities).
• Oversee inspection preparation, execution, and response, including management of commitments, CAPAs, and remediation activities.
• Conduct internal audits and mock inspections to proactively identify and mitigate compliance risks.
• Oversee key quality systems including deviations, CAPAs, change control, and quality metrics.
• Drive harmonization and optimization of QMS processes and digital platforms (e.g., Veeva, TrackWise).
• Establish and monitor quality KPIs to assess system effectiveness and inform executive decision-making.
• Champion a culture of quality, accountability, and continuous improvement across the organization.

Qualifications and Experience

• Advanced degree in a scientific discipline (MS, PhD, or equivalent preferred).
• 12+ years of experience in Quality Assurance/Compliance within the pharmaceutical or biotechnology industry.
• Demonstrated leadership experience in GMP, GCP, and/or GLP environments across development and commercial stages.
• Extensive experience with regulatory inspections and health authority interactions.
• Proven expertise in supplier quality management, product complaints, and inspection readiness.
• Strong knowledge of global regulatory requirements and guidelines (FDA, EMA, ICH).
• Experience with electronic Quality Management Systems (e.g., Veeva, TrackWise).
• Up to 30% travel required.