Senior Director, Quality Compliance

We're seeking a Senior Director, Quality Compliance, reporting to the VP, Head of Quality, to lead global quality compliance and GxP oversight across clinical development, commercialization, and post-market activities. A key focus is risk-based oversight of external GxP partners in a virtual operating model, ensuring regulatory compliance, effective governance, and inspection readiness.

The role partners with Clinical Development, Clinical Operations, Pharmacovigilance, CMC, Regulatory Affairs, Manufacturing, Supply Chain, and other functions to manage GxP compliance risks and maintain effective oversight of outsourced activities.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities (including, but not limited to)

GxP Quality Compliance and Supplier Oversight

• Develop and lead a risk-based GxP quality compliance and supplier oversight strategy across GMP/GDP, GCP, GVP, GLP, and other applicable regulated activities.
• Provide strategic Quality oversight of critical external partners, including CMOs, CROs, laboratories, clinical and pharmacovigilance service providers, and distribution partners.
• Oversee supplier qualification, risk assessment, audits, quality agreements, performance monitoring, periodic review, governance, escalation, and ongoing compliance.
• Ensure effective oversight of outsourced GxP activities in a virtual operating model, with clear responsibilities, governance, escalation, and documented evidence of oversight.
• Provide GCP and GVP Quality oversight, including CRO, clinical service provider, and pharmacovigilance vendor compliance, audits, significant quality issues, and inspection readiness.
• Partner cross-functionally to identify and manage GxP compliance risks and ensure supplier oversight supports both clinical and commercial operations.

Clinical and Commercial Quality Compliance

• Provide Quality Compliance leadership across the product lifecycle, from clinical development through commercialization and post-market activities.
• Ensure quality systems and supplier oversight appropriately support clinical-stage and commercial-stage operations, including transition to commercialization.

Inspection Readiness and Regulatory Compliance

• Lead global inspection readiness across applicable GxP areas and ensure internal systems and external partner oversight remain inspection-ready.
• Serve as a senior Quality lead for health authority inspections and oversee preparation, execution, responses, commitments, and remediation.
• Oversee internal audits, supplier audits, mock inspections, and readiness assessments to proactively identify and mitigate compliance risks.
• Monitor regulatory developments and inspection trends and ensure appropriate actions are taken to maintain compliance.

Leadership and Cross-Functional Partnership

• Champion a culture of quality, accountability, continuous improvement, and proactive risk management.
• Lead and mentor Quality professionals and influence internal and external stakeholders to achieve compliance and business objectives.
• Apply strategic thinking, executive communication, and risk-based decision-making to complex quality and compliance challenges.

Standout Skills for Impact

• Enterprise-wide GxP quality compliance and external partner oversight in a virtual and highly outsourced operating model.
• Broad GxP expertise with demonstrated GCP and GVP supplier and partner oversight experience.
• Clinical-to-commercial Quality leadership and continuous inspection readiness.
• Risk-based governance, executive influence, and resolution of complex cross-functional compliance challenges.

Qualifications and Experience

• Advanced degree in a scientific or related discipline (MS, PhD, or equivalent preferred).
• 12+ years of progressive Quality Assurance/Compliance experience in the pharmaceutical or biotechnology industry.
• Demonstrated leadership across multiple GxP areas and experience supporting both clinical and commercial operations.
• Significant experience overseeing GxP suppliers and external partners in a virtual or highly outsourced operating model.
• Demonstrated GCP Quality experience, including oversight of CROs and clinical service providers, audits, compliance management, and inspection readiness.
• Demonstrated GVP Quality experience, including oversight of pharmacovigilance vendors and outsourced safety activities, audits, compliance management, and inspection readiness.
• Strong GMP/GDP supplier oversight experience, including CMOs, laboratories, and distribution/logistics providers.
• Extensive regulatory inspection and health authority interaction experience, including inspection preparation, execution, responses, and remediation.
• Strong knowledge of applicable global regulatory requirements and industry expectations, including FDA, EMA, MHRA, and ICH.
• Experience with electronic Quality Management Systems such as Veeva or TrackWise.
• Strong executive communication, influencing, cross-functional leadership, and risk-based decision-making skills.
• Up to 30% travel required.

Pay Range 250000 - 273000 USD