Senior Quality Assurance Specialist (CMC)
$84,000–$105,000 year
On-siteBedford, Massachusetts, United States
Job Summary
Senior Quality Assurance Specialist provides quality oversight across GMP manufacturing activities for drug substance and drug product operations, external partners, and CDMOs; reviews and approves GMP documentation (batch records, SOPs, protocols, validation reports, stability reports, investigations) to ensure compliance with regulatory requirements; supports batch disposition and cGMP release; partners with CMC, Technical Operations, and cross-functional teams to support technology transfer, process scale-up, process validation, and manufacturing readiness; drives deviations, CAPAs, and change controls lifecycle; identifies quality risks and implements practical mitigation; supports QMS maintenance and continuous improvement; ensures inspection readiness and compliance with FDA, EMA, ICH, and other regulatory expectations; develops and maintains quality procedures, leads internal/supplier/CDMO audits, and supports audit responses; maintains traceability and integrity of GMP records; collaborates across teams and external partners to enable program execution.
Required Qualifications
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Engineering, or a related scientific discipline; advanced degree preferred.
- Minimum of 5 years of Quality Assurance experience within the biotechnology or pharmaceutical industry operating under GMP regulations.
- Strong working knowledge of FDA and EMA cGMP regulations and applicable ICH guidelines, including Q7, Q8, Q9, and Q10.
- Experience supporting pharmaceutical manufacturing operations and providing quality oversight of suppliers, contract manufacturers, and CDMOs.
- Experience reviewing and approving GMP documentation, investigations, deviations, CAPAs, change controls, and validation-related documentation.
- Working knowledge of Quality Management Systems and regulatory inspection readiness practices.
- Strong written and verbal communication skills with the ability to effectively collaborate across functional teams and external partners.
Desired Qualifications
- Advanced degree in a scientific, engineering, or related discipline.
- Experience supporting CMC development activities, analytical development programs, and technology transfer initiatives.
- Thorough understanding of pharmaceutical and medical device Quality Management Systems.
- Experience supporting regulatory inspections and responding to audit observations and regulatory findings.
- Knowledge of process validation, cleaning validation, and pharmaceutical manufacturing lifecycle activities.
- Experience working in both commercial-stage and development-stage GMP environments.
- Demonstrated ability to drive continuous improvement initiatives and implement pragmatic, risk-based quality solutions.
- The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location.…
- The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.
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