Sr. Director, Quality Compliance

Key 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 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 (timely investigation, trending, and closure).
- Ensure regulatory reporting compliance, including Field Alert Reports (FARs), Biological Product Deviation Reports (BPDRs), and other post-market obligations.
- Drive continuous improvement in complaint handling, 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 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 commitments, CAPAs, and remediation activities.
- Conduct internal audits and mock inspections to identify and mitigate compliance risks.
- Oversee deviations, CAPAs, change control, and quality metrics.
- Harmonize and optimize 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.
- Lead, develop, and mentor quality teams across multiple regions.
- Collaborate with CMC, Regulatory Affairs, Clinical, Pharmacovigilance, and Supply Chain for integrated quality oversight.
- Influence and align stakeholders to drive compliance and business objectives.

Qualifications
- 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.
- 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).

Pay
- $250,000 - $273,000 (compensation subject to change based on industry standards and relevant experience/qualifications).