Sr Manager, QA Operations
Emergent BioSolutions
June 29, 2026
On-site
Canton, MA
Operations
Job Summary
The Senior Manager, Quality Assurance Operations provides senior leadership and oversight of GMP Quality Assurance Operations at a vaccine Drug Substance manufacturing site, ensuring compliant execution of manufacturing activities and effective implementation of site quality systems.
Essential Functions / Responsibilities
- Provide senior QA oversight for GMP manufacturing operations; maintain robust QA presence for real-time decisions, logbook and batch documentation reviews, and issue resolution.
- Lead and oversee Deviations, CAPAs, Change Controls, Effectiveness Checks, and other site quality systems; ensure timely, high-quality investigations with root cause analysis.
- Apply Quality Risk Management (ICH Q9) to assess, escalate, and mitigate quality/compliance risks; identify adverse trends and support escalation.
- Provide QA oversight and approval for qualification/validation protocols, reports, and deviations for facilities, utilities, equipment, processes, QC methods, and computerized systems.
- Support internal audits and regulatory inspections; act as a Subject Matter Expert and ensure inspection readiness for FDA (CBER), global health authorities, and partner audits.
- Develop and present KPIs for Quality Management Review (QMR) and communicate quality performance.
- Lead, coach, and develop QA Operations personnel; promote cross-training and continuous improvement.
- Provide QA leadership for technology transfers, lifecycle changes, and new/modified processes; partner with Supplier Quality and Compliance.
Qualifications
- Bachelor’s degree in Biological Sciences, Chemistry, Engineering, or related scientific discipline (required); advanced degree preferred.
- 8–10+ years progressive GMP Quality experience in pharma/biotech; demonstrated biologics/vaccine Drug Substance experience.
- Proven QA Operations/Quality Systems leadership in regulated manufacturing; prior regulatory inspection/audit and inspection readiness experience.
- Experience with technical transfers, validation, cross-functional quality initiatives; required people leadership experience.
Skills
- Strong CGMP knowledge (FDA/EMA/ICH); risk assessment and complex data interpretation; excellent written/verbal communication.
- Ability to critically review/approve SOPs, validation documents, investigations, protocols, and regulatory responses.
- Strong organization/multi-priority management; proficiency with MS Office and eQMS.
Benefits (if selected)
- Estimated base salary range: $171,500–$207,500; eligibility for additional incentive compensation may apply. Comprehensive benefits package offered.
Application Instructions
- If selected for an interview, discuss compensation philosophy and benefits with a Human Resources Partner.
The Senior Manager, Quality Assurance Operations provides senior leadership and oversight of GMP Quality Assurance Operations at a vaccine Drug Substance manufacturing site, ensuring compliant execution of manufacturing activities and effective implementation of site quality systems.
Essential Functions / Responsibilities
- Provide senior QA oversight for GMP manufacturing operations; maintain robust QA presence for real-time decisions, logbook and batch documentation reviews, and issue resolution.
- Lead and oversee Deviations, CAPAs, Change Controls, Effectiveness Checks, and other site quality systems; ensure timely, high-quality investigations with root cause analysis.
- Apply Quality Risk Management (ICH Q9) to assess, escalate, and mitigate quality/compliance risks; identify adverse trends and support escalation.
- Provide QA oversight and approval for qualification/validation protocols, reports, and deviations for facilities, utilities, equipment, processes, QC methods, and computerized systems.
- Support internal audits and regulatory inspections; act as a Subject Matter Expert and ensure inspection readiness for FDA (CBER), global health authorities, and partner audits.
- Develop and present KPIs for Quality Management Review (QMR) and communicate quality performance.
- Lead, coach, and develop QA Operations personnel; promote cross-training and continuous improvement.
- Provide QA leadership for technology transfers, lifecycle changes, and new/modified processes; partner with Supplier Quality and Compliance.
Qualifications
- Bachelor’s degree in Biological Sciences, Chemistry, Engineering, or related scientific discipline (required); advanced degree preferred.
- 8–10+ years progressive GMP Quality experience in pharma/biotech; demonstrated biologics/vaccine Drug Substance experience.
- Proven QA Operations/Quality Systems leadership in regulated manufacturing; prior regulatory inspection/audit and inspection readiness experience.
- Experience with technical transfers, validation, cross-functional quality initiatives; required people leadership experience.
Skills
- Strong CGMP knowledge (FDA/EMA/ICH); risk assessment and complex data interpretation; excellent written/verbal communication.
- Ability to critically review/approve SOPs, validation documents, investigations, protocols, and regulatory responses.
- Strong organization/multi-priority management; proficiency with MS Office and eQMS.
Benefits (if selected)
- Estimated base salary range: $171,500–$207,500; eligibility for additional incentive compensation may apply. Comprehensive benefits package offered.
Application Instructions
- If selected for an interview, discuss compensation philosophy and benefits with a Human Resources Partner.