Senior Specialist, Quality Assurance - Drug Product

About the role

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. This role focuses on batch record review, vendor oversight, and ensuring the accuracy and completeness of GMP documentation across internal and external manufacturing operations. The individual will work closely with contract manufacturers to support tech transfer, process validation, and routine GMP operations.

Responsibilities

• QA Systems Execution & SOP Support: Support the implementation, revision, and maintenance of QA programs, policies, and procedures to ensure compliance with cGMP, FDA, and ICH requirements. Assist in updating SOPs to mitigate compliance gaps and support commercial QA readiness.
• Tech Transfer & Process Validation Support: Support QA activities related to drug product tech transfer and preparation for and execution of process validation. Ensure QA compliance of validation protocols, reports, and associated documentation during execution.
• Batch Record Review & GMP Batch Disposition Support: Perform QA review of batch records, validation and analytical documentation to ensure accuracy, completeness, and compliance with GMP standards. Support timely batch disposition once all required data is available.
• Vendor QA Oversight Support: Serve as a QA point of contact for assigned contract manufacturers and partners by supporting QA oversight activities, including oversight participation in manufacturing, validation, change management, and deviation processes to ensure GMP compliance.
• GMP Auditing & Inspection Readiness: Support and participate in GMP audits for vendor qualification or requalification, including preparation, execution support, and documentation of findings. Assist in maintaining inspection readiness for internal and external stakeholders.
• Documentation & Analytical Review: Perform QA review of manufacturing, validation, and analytical documents related to release testing, stability studies, and method validation to ensure compliance with regulatory expectations.
• Quality Event Management Support: Support the review and resolution of quality system events, including deviations, CAPAs, change controls, and out-of-specification investigations. Ensure proper documentation and timely follow-up to support effective closure.
• Cross-Functional Collaboration & Continuous Improvement: Collaborate with internal teams and external partners to ensure QA requirements are met across manufacturing and quality processes. Identify and support improvements to QA systems, documentation workflows, and compliance processes.

Qualifications

• Bachelor’s degree (BS/BA) in a relevant scientific discipline (e.g., Biology, Chemistry, Pharmaceutical Sciences, or related field).
• Minimum of four to six (4–6) 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.