Sr Manager, QA Operations
Emergent BioSolutions
August 15, 2026
On-site
Canton, MA
Operations
Senior Manager, Quality Assurance Operations (GMP) — Responsibilities
- Provide senior QA oversight for GMP vaccine Drug Substance manufacturing, ensuring controls are executed per procedures/regulations; maintain QA presence for real-time decisions, logbook/batch documentation review, and issue resolution.
- Lead Quality systems: Deviations, CAPAs, Change Controls, Effectiveness Checks; ensure timely, high-quality investigations with sound root-cause analysis and risk-based decisions.
- Apply ICH Q9 Quality Risk Management to assess/escalate/mitigate risks; partner on risk assessments and trend escalation.
- Oversee/approve qualification & validation protocols, reports, and deviations for facilities, utilities, equipment, processes, QC methods, and computerized systems.
- Support internal audits and regulatory inspections; serve as Subject Matter Expert and support remediation (FDA (CBER), global health authorities, partner audits).
- Develop and present KPIs supporting Quality Management Review (QMR); communicate quality performance and state of control.
- Lead/coach QA Operations personnel; promote cross-training and continuous improvement.
- Provide QA leadership for technology transfer and lifecycle changes; collaborate with Supplier Quality and Compliance.
Qualifications
- Bachelor’s degree in Biological Sciences, Chemistry, Engineering, or related field (required); advanced degree preferred.
- 8–10+ years progressive GMP Quality experience (pharma/biotech); biologics/vaccine Drug Substance experience.
- Proven leadership in QA Operations/Quality Systems in regulated manufacturing; experience supporting inspections, internal audits, inspection readiness, technical transfers, validation, and cross-functional quality initiatives.
- Prior people leadership required.
Skills
- Strong CGMP/ICH/FDA-EMA knowledge; risk assessment and complex data interpretation; excellent communication; ability to review/approve SOPs, validation/investigation/protocol/regulatory responses.
- Proficiency with MS Office and eQMS.
Compensation/Benefits
- Base pay range: $171,500–$207,500 (plus potential incentive compensation).
- Comprehensive benefits package.
Application instruction
- If selected for an interview, speak with an HR Partner about compensation philosophy and benefits.
- Provide senior QA oversight for GMP vaccine Drug Substance manufacturing, ensuring controls are executed per procedures/regulations; maintain QA presence for real-time decisions, logbook/batch documentation review, and issue resolution.
- Lead Quality systems: Deviations, CAPAs, Change Controls, Effectiveness Checks; ensure timely, high-quality investigations with sound root-cause analysis and risk-based decisions.
- Apply ICH Q9 Quality Risk Management to assess/escalate/mitigate risks; partner on risk assessments and trend escalation.
- Oversee/approve qualification & validation protocols, reports, and deviations for facilities, utilities, equipment, processes, QC methods, and computerized systems.
- Support internal audits and regulatory inspections; serve as Subject Matter Expert and support remediation (FDA (CBER), global health authorities, partner audits).
- Develop and present KPIs supporting Quality Management Review (QMR); communicate quality performance and state of control.
- Lead/coach QA Operations personnel; promote cross-training and continuous improvement.
- Provide QA leadership for technology transfer and lifecycle changes; collaborate with Supplier Quality and Compliance.
Qualifications
- Bachelor’s degree in Biological Sciences, Chemistry, Engineering, or related field (required); advanced degree preferred.
- 8–10+ years progressive GMP Quality experience (pharma/biotech); biologics/vaccine Drug Substance experience.
- Proven leadership in QA Operations/Quality Systems in regulated manufacturing; experience supporting inspections, internal audits, inspection readiness, technical transfers, validation, and cross-functional quality initiatives.
- Prior people leadership required.
Skills
- Strong CGMP/ICH/FDA-EMA knowledge; risk assessment and complex data interpretation; excellent communication; ability to review/approve SOPs, validation/investigation/protocol/regulatory responses.
- Proficiency with MS Office and eQMS.
Compensation/Benefits
- Base pay range: $171,500–$207,500 (plus potential incentive compensation).
- Comprehensive benefits package.
Application instruction
- If selected for an interview, speak with an HR Partner about compensation philosophy and benefits.