Senior Director, Quality Compliance

Responsibilities (including, but not limited to):

The Senior Director, Quality Compliance is responsible for providing strategic leadership and oversight of the organization’s global quality compliance programs, ensuring alignment with regulatory requirements and industry best practices. This role leads key quality systems including supplier oversight, product complaints, and inspection readiness, and partners cross-functionally to drive a proactive, risk-based quality culture that supports development through commercialization.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week with up to 30% travel required.

Standout Skills for Impact: 

Quality Compliance Strategy & Governance

• 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.

Supplier & External Partner Oversight

• 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.

Product Quality Complaints

• 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.

Inspection Readiness & Regulatory Engagement

• 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.

Quality Systems & Continuous Improvement

• 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.

Leadership 

• Strategic thinking and enterprise mindset


• Executive communication and influence


• Risk-based decision making


• Change leadership and quality culture transformation


• Operational excellence and continuous improvement

Leadership & Cross-Functional Collaboration

• Lead, develop, and mentor high-performing quality teams across multiple regions.


• Collaborate with CMC, Regulatory Affairs, Clinical, Pharmacovigilance, and Supply Chain to ensure integrated quality oversight.


• Influence and align stakeholders at all levels to drive compliance and business objectives.

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)