Senior Specialist, Quality Assurance – Drug Product

Senior Specialist, Quality Assurance – Drug Product

The Senior Specialist, Quality Assurance – Drug Product is responsible for executing quality assurance activities that support clinical and commercial manufacturing operations in compliance with cGMP standards.

• Batch record review
• Vendor oversight and ensuring the accuracy and completeness of GMP documentation across internal and external manufacturing operations
• Work closely with contract manufacturers to support tech transfer, process validation, and routine GMP operations
• Manage multiple priorities and collaborate cross‑functionally to ensure timely batch disposition and compliance
• Serve as a key contributor within the QA team, supporting inspection readiness and continuous improvement of the GMP Quality System while providing occasional support for clinical labeling, drug substance contract manufacturing, and other QA activities as needed

Requirements

• Bachelor’s degree (BS/BA) in a relevant scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, or related field).
• Minimum of four to six years of experience in Quality Assurance and/or Quality Systems within the biotechnology or pharmaceutical industry.
• Direct experience supporting GMP‑regulated drug product manufacturing, including batch record review and documentation compliance.
• Experience supporting contract manufacturing organizations (CMOs) or external vendors in a QA capacity.
• Hands‑on experience with quality systems such as deviations, CAPAs, change control, and/or OOS investigations.
• Working knowledge of cGMP regulations, FDA guidelines, ICH standards, and industry best practices related to drug product manufacturing.
• Ability to review and interpret technical documentation (batch records, validation protocols/reports, analytical data).
• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.
• Proficiency with electronic quality systems and document management platforms.
• Ability to travel domestically and internationally (~20%) as needed.