Sr Manager, QA Compliance
Emergent BioSolutions
June 24, 2026
On-site
Canton, MA
Operations
Job Summary:
The Sr. Manager, QA Compliance is responsible for ensuring continuous GMP compliance, inspection readiness, and supplier quality oversight for a vaccine Drug Substance (DS) manufacturing site in Canton, MA. Primary accountability includes internal audit programs, regulatory inspection preparedness/execution, and site implementation of global supplier quality and compliance strategies.
Essential Functions:
- Own and lead site GMP audit readiness (internal, supplier, corporate, client, and regulatory).
- Manage and execute the site Internal Audit Program (risk-based planning, auditor qualification, execution, reporting/escalation, effectiveness checks).
- Lead regulatory inspection preparedness/hosting/response (FDA CBER and other global health authorities).
- Provide Supplier Quality Management leadership (supplier qualification, performance monitoring, supplier audits, SCNs, SCARs).
- Partner with Global Process Owners to deploy/sustain/improve global Quality Management Systems and Quality Risk Management.
- Ensure Quality Agreements for GMP suppliers and service providers.
- Serve as site Subject Matter Expert for GMP compliance, audit execution, inspection readiness, and supplier quality.
- Oversee Quality Management Reviews (QMRs) and present quality metrics to Site Leadership.
- Provide oversight for deviations, CAPAs, and change controls with potential compliance/supplier quality impact.
- Ensure alignment of raw material specs, Approved Supplier Lists, and supplier documentation with filings/global standards.
- Lead, develop, and mentor Quality Compliance and Supplier Quality personnel.
- Drive continuous improvement to strengthen compliance and improve inspection outcomes/supplier performance.
- Communicate/escalate quality risks while maintaining Quality Unit independence.
Qualifications:
- Bachelor’s degree in Biological Sciences, Chemistry, Engineering, or related field; Master’s/PhD preferred.
- 8–10 years progressive GMP Quality experience in biopharma/vaccine/sterile DS manufacturing.
- Experience leading GMP compliance programs, internal audits, regulatory inspections, and supplier quality management (CBER strongly preferred).
- People leadership experience (direct management, coaching, development).
- Knowledge of U.S./global GMP regulations (21 CFR 210/211/600, ICH Q7/Q9/Q10, FDA guidance).
- Strong supplier qualification, auditing, quality agreements, and supplier performance management.
- Independent judgment and risk-based decision-making with appropriate escalation.
- Excellent written/verbal communication; strong analytical skills.
- Matrix/global influence experience.
- Proficiency with electronic QMS, EDMS, audit tools, and MS Office.
Compensation/Benefits:
- Estimated base salary range: $171,500–$207,500; may include additional incentive compensation (e.g., bonus and/or long-term incentives).
- Comprehensive benefits package (eligibility governed by plan documents).
Application instructions:
- If selected for an interview, speak with an HR Partner about compensation philosophy and benefits.
The Sr. Manager, QA Compliance is responsible for ensuring continuous GMP compliance, inspection readiness, and supplier quality oversight for a vaccine Drug Substance (DS) manufacturing site in Canton, MA. Primary accountability includes internal audit programs, regulatory inspection preparedness/execution, and site implementation of global supplier quality and compliance strategies.
Essential Functions:
- Own and lead site GMP audit readiness (internal, supplier, corporate, client, and regulatory).
- Manage and execute the site Internal Audit Program (risk-based planning, auditor qualification, execution, reporting/escalation, effectiveness checks).
- Lead regulatory inspection preparedness/hosting/response (FDA CBER and other global health authorities).
- Provide Supplier Quality Management leadership (supplier qualification, performance monitoring, supplier audits, SCNs, SCARs).
- Partner with Global Process Owners to deploy/sustain/improve global Quality Management Systems and Quality Risk Management.
- Ensure Quality Agreements for GMP suppliers and service providers.
- Serve as site Subject Matter Expert for GMP compliance, audit execution, inspection readiness, and supplier quality.
- Oversee Quality Management Reviews (QMRs) and present quality metrics to Site Leadership.
- Provide oversight for deviations, CAPAs, and change controls with potential compliance/supplier quality impact.
- Ensure alignment of raw material specs, Approved Supplier Lists, and supplier documentation with filings/global standards.
- Lead, develop, and mentor Quality Compliance and Supplier Quality personnel.
- Drive continuous improvement to strengthen compliance and improve inspection outcomes/supplier performance.
- Communicate/escalate quality risks while maintaining Quality Unit independence.
Qualifications:
- Bachelor’s degree in Biological Sciences, Chemistry, Engineering, or related field; Master’s/PhD preferred.
- 8–10 years progressive GMP Quality experience in biopharma/vaccine/sterile DS manufacturing.
- Experience leading GMP compliance programs, internal audits, regulatory inspections, and supplier quality management (CBER strongly preferred).
- People leadership experience (direct management, coaching, development).
- Knowledge of U.S./global GMP regulations (21 CFR 210/211/600, ICH Q7/Q9/Q10, FDA guidance).
- Strong supplier qualification, auditing, quality agreements, and supplier performance management.
- Independent judgment and risk-based decision-making with appropriate escalation.
- Excellent written/verbal communication; strong analytical skills.
- Matrix/global influence experience.
- Proficiency with electronic QMS, EDMS, audit tools, and MS Office.
Compensation/Benefits:
- Estimated base salary range: $171,500–$207,500; may include additional incentive compensation (e.g., bonus and/or long-term incentives).
- Comprehensive benefits package (eligibility governed by plan documents).
Application instructions:
- If selected for an interview, speak with an HR Partner about compensation philosophy and benefits.