Senior Specialist, Quality Assurance Operations

About the role

As Quality Assurance Drug Substance (DS) Specialist, you will be responsible for Quality Assurance activities at the new gene therapy manufacturing facility located in Bedford, MA. You will provide direct QA oversight and support for the core Drug Substance Manufacturing activities, including Production Batch Record review, deviation management, QA Manufacturing walkthroughs, logbook review and room/equipment tag-out for manufacturing use. The site is a multi-product facility used for drug substance manufacturing and aseptic filling of drug product; QA activities are primarily focused on the drug substance manufacturing areas but may also support Drug Product when required. You will partner with Manufacturing, Engineering, Validation, QC, Quality Systems, and MSAT functions to provide QA approval for operating procedures, DS manufacturing processes, and batch records required for ongoing manufacturing at the facility.

Responsibilities

• Review and approval of Master Batch Records and executed DS Production Batch Records
• QA review and approval of DS area shutdowns/restarts after planned or unplanned maintenance/EM events
• Perform routine area walkthroughs, logbook reviews, and inspection readiness assessments
• Write, review, and/or approve documents such as SOPs, work instructions, policies, and standards to enable GMP manufacturing execution
• Work with various functions to resolve deviations and assess potential product and compliance impact
• Escalate significant events to Quality Management and drive timely completion of effective investigations
• Drive or support continuous improvement activities to eliminate waste and enable an effective and efficient manufacturing site/process
• Champion process improvement where applicable

Requirements

• Minimum B.S. degree in a scientific field such as microbiology, chemistry, or biochemistry
• 5+ years of experience in biopharmaceutical, biotechnology, cell or gene therapy industries with Manufacturing and Quality roles
• Direct experience working at a biologic or advanced therapy medicinal product (ATMP) manufacturing site
• Knowledge and experience with drug substance and aseptic practices
• Knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products
• Demonstrated ability to communicate technical information or complex situations to site management and/or health authority inspectors in a concise and clear manner

Physical Demands / Work Environment / Safety Considerations

• Stand for extended periods with periodic stooping, bending, or kneeling
• Ability to lift, push, or pull up to 50 lbs
• Climb ladders and stairs of various heights
• Work in a controlled environment requiring GxP gowning and protective clothing over the head, face, hands, feet, and body; ability to change clothes into appropriate gowning and PPE
• Tasks may require use of a respirator; medical clearance will be required in advance
• Remove all makeup, jewelry, and contact lenses while in the manufacturing environment
• Work in temperature-controlled environments (cold rooms)

Pay

The typical annual salary range for this full-time position is $105,300—$130,100 USD. The range reflects the characteristics of the job and may be adjusted based on the applicant’s geographic location. This position is eligible for an annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.

Benefits

• Generous vacation time and company-observed public holidays
• Volunteer days
• Long-term incentive and employee stock purchase plans or equivalent offerings
• Employee wellbeing benefits and fitness reimbursement
• Tuition sponsorship and professional development plans
• Benefits vary by region and country

Schedule

This position follows a Wednesday–Saturday schedule with four 10-hour workdays and flexibility to start between 7:00 am and 8:30 am to support operational activities.