Manager, Quality Assurance GMP

About the role

The Manager, Quality Assurance GMP will manage quality assurance functions related to commercialization, clinical development, and regulatory compliance of products. This role is responsible for supporting the development, implementation, and maintenance of QA systems and activities, ensuring compliance with GMP standards. The Manager will lead audits, manage quality investigations, and collaborate with internal teams and external partners to resolve product quality issues. The role also includes oversight of documentation related to GMP activities. This role will support the Commercial Quality Assurance organization.

Essential Functions

• QA Program Development: Support the development, improvement, and management of QA programs, policies, and procedures to ensure cGMP compliance.
• Vendor and Partner Management: Serve as the QA contact for specified vendors, contract facilities, or joint development collaborators. Through QA oversight, project team participation, and QA representation for batch manufacture oversight, validation activities, change management, and other GMP related activities, ensure cGMP requirements are met.
• Support the process for Sponsor batch disposition.
• Document Review and Management: Perform QA review of manufacturing records, validation related records, batch records, and documents submitted to regulatory agencies.
• GMP Auditing and Inspections: Lead cGMP auditing of vendors. Support inspection readiness programs to ensure that the Sponsor and vendors have successful inspectional outcomes.
• Analytical Document Review: Review analytical documents related to release testing, stability testing, reference standards, and analytical method qualification/validation.
• Issue Resolution: Provide input on the vendor’s Quality System events, including change control, deviations, investigation, out-of-specifications, and CAPAs.
• Other: Perform other related duties as assigned or requested

Qualifications

• BS/BA in a relevant scientific discipline.
• At least five (5) years of experience in Quality Systems and Quality Assurance processes, including development and documentation.
• A minimum of three (3) years demonstrating management of QA projects including directing and organizing personnel to complete critical timeline objectives.
• Experience with commercial drug manufacturing and manufacturing process validation; familiarity with Federal laws and regulations affecting the pharmaceutical industry.
• Experience of managing contract manufacturers with direct operational QA oversight responsibilities.