Senior Quality Assurance Specialist (CMC)
Anika
June 26, 2026
Remote friendly (Bedford, MA)
United States
$84,000 - $105,000 USD yearly
Operations
Responsibilities:
- Provide quality oversight for GMP manufacturing (drug substance and drug product), including external manufacturing partners and CDMOs.
- Review/approve GMP documentation (batch records, SOPs, protocols, validation and stability reports, investigations, and other quality records).
- Support batch disposition and ensure products are manufactured, tested, and released per cGMP.
- Partner with CMC, Technical Operations, and cross-functional teams for technology transfer, process scale-up, process validation, and manufacturing readiness.
- Manage deviations, CAPAs, and change controls (initiation, investigation, closure, and effectiveness monitoring).
- Identify/communicate quality risks and drive compliant mitigation strategies.
- Support QMS implementation/maintenance/continuous improvement (deviations, CAPA, change control, document control, training, quality risk management).
- Assess quality systems vs. FDA/EMA/ICH expectations; drive inspection-ready improvements.
- Develop/revise quality procedures and SOPs.
- Support internal/supplier/CDMO audits; conduct gap assessments, mock inspections, and remediation.
- Draft/review responses to audit observations and inspection outcomes.
Qualifications (What You Bring):
- Bachelor’s degree (Chemistry, Pharmaceutical Sciences, Engineering, or related); advanced degree preferred.
- 5+ years QA experience in biotechnology/pharma under GMP.
- Working knowledge of FDA/EMA cGMP and ICH Q7/Q8/Q9/Q10.
- Experience overseeing suppliers/CDMOs and reviewing/approving GMP documentation, investigations, deviations, CAPAs, change controls, and validation-related documents.
- Working knowledge of QMS and inspection readiness.
- Strong written/verbal communication.
Nice to Have:
- CMC/analytical development/technology transfer experience; regulatory inspection response; validation/cleaning validation; commercial + development GMP; continuous improvement.
Benefits/Compensation (if applicable): discretionary bonus; healthcare benefits, HSA, 401(k) up to 5% match, stock purchase plan, paid time off, long-term incentives/stock awards.
- Provide quality oversight for GMP manufacturing (drug substance and drug product), including external manufacturing partners and CDMOs.
- Review/approve GMP documentation (batch records, SOPs, protocols, validation and stability reports, investigations, and other quality records).
- Support batch disposition and ensure products are manufactured, tested, and released per cGMP.
- Partner with CMC, Technical Operations, and cross-functional teams for technology transfer, process scale-up, process validation, and manufacturing readiness.
- Manage deviations, CAPAs, and change controls (initiation, investigation, closure, and effectiveness monitoring).
- Identify/communicate quality risks and drive compliant mitigation strategies.
- Support QMS implementation/maintenance/continuous improvement (deviations, CAPA, change control, document control, training, quality risk management).
- Assess quality systems vs. FDA/EMA/ICH expectations; drive inspection-ready improvements.
- Develop/revise quality procedures and SOPs.
- Support internal/supplier/CDMO audits; conduct gap assessments, mock inspections, and remediation.
- Draft/review responses to audit observations and inspection outcomes.
Qualifications (What You Bring):
- Bachelor’s degree (Chemistry, Pharmaceutical Sciences, Engineering, or related); advanced degree preferred.
- 5+ years QA experience in biotechnology/pharma under GMP.
- Working knowledge of FDA/EMA cGMP and ICH Q7/Q8/Q9/Q10.
- Experience overseeing suppliers/CDMOs and reviewing/approving GMP documentation, investigations, deviations, CAPAs, change controls, and validation-related documents.
- Working knowledge of QMS and inspection readiness.
- Strong written/verbal communication.
Nice to Have:
- CMC/analytical development/technology transfer experience; regulatory inspection response; validation/cleaning validation; commercial + development GMP; continuous improvement.
Benefits/Compensation (if applicable): discretionary bonus; healthcare benefits, HSA, 401(k) up to 5% match, stock purchase plan, paid time off, long-term incentives/stock awards.