Job Title: Quality Assurance Manager

Duration: 12 Months

Location: Cambridge, MA 02139

Description :

• Issue, review, and approve GMP documentation (e.g., batch records, SOPs, job aids, etc.) needed for internal manufacturing operations.

• Review logbooks and reconcile documentation.

• Assist with walkthroughs with senior Quality staff members.

• Review labeling and packaging batch records and prepare documentation for release.

• Review work orders, equipment qualification, and validation documentation for adequacy and compliance.

• Review batch record documentation, ensure compliance and accuracy, and prepare for drug substance/product and/or critical material release.

• Engage in daily onsite quality oversight and guidance and collaborate across functions, leveraging quality and manufacturing expertise to provide guidance on non-conformance/deviations, troubleshoot/problem solve, interpret data, and apply a risk-based approach for ongoing manufacturing operations and related quality events.

• Represent QA in onsite operations from the thaw of starting material to drug substance/product filling and labeling.

• Additional duties as assigned.

Minimum requirements:

o Bachelor’s Degree in Biology, Microbiology, Chemistry or related field

o 4+ years of experience in cGMP Quality Assurance in Biologics or Cell & Gene Therapy product manufacturing

Preferred requirements:

o Master’s Degree in Microbiology, Biology, Chemistry or a related field

o Working knowledge of cell or gene therapy product testing, manufacturing, or development

• Demonstrated knowledge of current GMP regulations associated with pharmaceuticals, cell therapies, gene therapies, etc. in the field of responsibility.

• Understanding and working knowledge of Quality Management System expectations, ability to interpret requirements, anticipate issues, make informed decisions, and respond rapidly to emerging quality situations. in the field of responsibility.

• Local travel between manufacturing sites required.