Sr Manager, QA Compliance

Sr Manager, QA Compliance

Location:

Canton, MA, US, 02021 Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

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. The role has primary accountability for internal audit programs, regulatory inspection preparedness and execution, and site-level implementation of global supplier quality and compliance strategies. This position partners closely with Site Leadership, Global Process Owners (GPOs) of Quality Management Systems (QMS), Manufacturing, Supply Chain, MSAT, and Global Quality to ensure alignment with global standards, regulatory expectations (FDA/CBER and global health authorities), and industry best practices.

The incumbent serves as a key member of Site Quality Management, providing independent quality oversight, risk-based decision making, and leadership to ensure reliable supply of compliant vaccine drug substance.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. 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. Ensure effective communication and escalation of quality risks and compliance issues to Site Leadership and Global Quality Management, maintaining Quality Unit independence.

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.

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…