Sr Manager, QA Compliance

About the role

The Sr. Manager, QA Compliance is a senior site Quality leader responsible for ensuring continuous GMP compliance, inspection readiness, and robust supplier quality oversight for a vaccine Drug Substance (DS) manufacturing site in Canton, MA.

Responsibilities

• Own and lead site GMP audit readiness, including internal (self-inspections), supplier, corporate, client, and regulatory inspections, ensuring a sustained state of inspection readiness at all times.
• Manage and execute the site Internal Audit Program, including risk-based audit planning, auditor qualification, audit execution, reporting, escalation of critical findings, and effectiveness checks.
• Lead regulatory inspection preparedness, hosting, and response activities for FDA (CBER) and other global health authorities; ensure timely, thorough, and compliant responses to inspection observations.
• Provide site leadership for Supplier Quality Management in alignment with global GxP Supplier Quality programs, including supplier qualification, performance monitoring, supplier audits, Supplier Change Notifications (SCNs), and Supplier Corrective Action Requests (SCARs).
• Partner with Global Process Owners (GPOs) to deploy, sustain, and continuously improve global Quality Management Systems related to compliance, audits, supplier quality, self-assessments, and Quality Risk Management.
• Ensure Quality Agreements are established, maintained, and implemented for GMP suppliers and service providers in accordance with global procedures.
• Serve as the site Subject Matter Expert for GMP compliance, audit execution, inspection readiness, and supplier quality-related matters, providing clear interpretation of regulatory and internal requirements.
• Oversee Quality Management Reviews (QMRs) related to compliance and supplier performance, including preparation, data analysis, trending, and presentation of key quality metrics to Site Leadership.
• Provide quality oversight and guidance to site deviation investigations, CAPAs, and change controls with potential compliance or supplier quality impact, ensuring risk-based, timely, and effective resolution.
• Ensure alignment of raw material specifications, Approved Supplier Lists (ASL), and supplier documentation with regulatory filings and global quality standards.
• Lead, develop, and mentor Quality Compliance and Supplier Quality personnel, fostering a strong quality culture, inspection readiness mindset, and continuous improvement.
• Drive continuous improvement initiatives focused on strengthening compliance, simplifying processes, enhancing inspection outcomes, and improving supplier performance and reliability.

Requirements

Bachelor’s degree in Biological Sciences, Chemistry, Engineering, or a related scientific discipline required; advanced degree (Master’s or PhD) preferred.

Minimum of 8–10 years of progressive GMP Quality experience within biopharmaceutical, vaccine, or sterile drug substance manufacturing environments.

Demonstrated experience leading GMP compliance programs, internal audits, regulatory inspections, and supplier quality management for FDA-regulated products (CBER experience strongly preferred).

Proven people leadership experience, including direct management, coaching, and development of Quality professionals.

In-depth knowledge of U.S. and global GMP regulations and guidelines, including 21 CFR Parts 210, 211, 600, ICH Q7, Q9, Q10, and applicable FDA guidance.

Strong working knowledge of supplier qualification, auditing, quality agreements, and supplier performance management within a global supply chain.

Demonstrated ability to operate independently within the Quality Unit, exercising sound judgment, risk-based decision making, and appropriate escalation.

Excellent written and verbal communication skills, with the ability to interface effectively with regulatory agencies, senior leadership, and cross-functional teams.

Strong analytical skills and ability to evaluate complex data, compliance trends, and quality metrics to support management decision-making.

Experience working effectively in a matrixed, global organization and influencing without direct authority.

Proficiency with electronic QMS, document management systems (EDMS), audit management tools, and standard business applications (e.g., MS Office).