Quality Assurance Manager Jobs

Position located in Cambridge, MA

Responsibilities of the Quality Assurance Manager:

• Conduct and assist in quality investigations/deviations, review corrective actions for adequacy and compliance, and ensure CAPA actions are identified and addressed.
• Draft and enforce Quality Agreements between external vendors and Relay as needed.
• Partner with CMC to support external manufacturing of Intermediates, DS, and DP and perform batch disposition activities.
• Partner within cross-functional teams as an experienced Quality technical resource.
• Collaborate with internal and external partners to navigate complex quality issues to ensure compliant solutions are implemented.
• Support internal and external audit programs, and support inspection readiness.
• Assess and approve change controls and may serve as change owner on behalf of QA. You will also assist change control owners with ensuring compliant change procedures and processes are followed.
• Assist in compiling data into metrics for use in Management Reviews and Quality Improvement initiatives.

Requirements of the Quality Assurance Manager:

• Bachelor’s degree in a scientific field.
• Experience working in a virtual environment.
• A combination of QA and relevant manufacturing experience may also be considered.
• Experience working with legacy and electronic quality systems.
• Strong knowledge of GXPs, with a focus on GMP and associated Analytical/QC testing.
• Comfortable interfacing with and working with external vendors.
• Minimum of 5 years of Quality Assurance experience in the pharmaceutical or biotech industry.