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CMC QA Associate

Bedford, MA 01730

Posted: 04/15/2025 Employment Type: Contract Job Category: Quality Job Number: 4349

Job Description


The CMC QA Consultant will report to the Senior Director of CMC QA and be responsible for supporting cross functional team (i.e. PD, MSAT, CMC, Manufacturing, Regulatory Affairs etc) to confirm the appropriate quality as well as compliant controls are in place for assigned Gene Therapy programs, and working with colleagues to improve processes utilized to ensure product quality. 

In this role, in collaboration with key stakeholders in Technical Operations, Regulatory Affairs and extended Quality (ie. QC, Supplier Quality), you will provide Quality oversight and support to ensure clinical through commercial development lifecycle activities for drug substance and drug product meet cGMP regulatory requirements and guidelines at GTMF and/or contract manufacturing organizations (CMO).

Responsibilities:
  • Support review and approval of process characterization studies and associated report
  • Provide quality oversight of process performance qualifications and associated studies
  • Review and approve process validation protocols and reports (i.e., Mixing validation, hold studies, extractable and leachable, impurity, column storage etc.)
  • Review and approve tech transfer plan, report, and associated deliverables
  • Author/Review of regulatory submissions and responses
  • Review and approve batch records, CC, deviations, and other quality systems
  • Support batch disposition and release
  • Quality Assurance Lead for the cross-functional CMC Sub-Teams
  • Provide quality oversight of process performance qualifications and associated studies
  • Support review and approval of process characterization studies and associated report
  • Review and approve process validation protocols and reports (i.e., Mixing validation, hold studies, extractable and leachable, impurity, column storage etc.)
  • Review and approve tech transfer plan, report, and associated deliverables
  • Author/Review of regulatory submissions and responses
  • Review and approve batch records, CC, deviations, and other quality systems
  • Support batch disposition and release
  • Ensure GMP processes are implemented in the Quality Management System (QMS) for clinical and commercial product process lifecycle (e.g. control strategy, technology transfer, process validation lifecycle, continuous process verification)
  • Provide oversight to ensure the creation of product specifications, method validation, stability, and comparability assessments for technology transfers are in accordance with global regulatory requirements and internal procedures/policies
  • Provide quality support for Quality System (i.e. Deviations/CAPA/Change Controls)
  • Author/review CMC sections of relevant regulatory dossiers and strategize responses to regulatory agency queries and Qualified Person (QP) queries throughout the product lifecycle 
  • Communicate and promote a culture of quality and operational excellence 


Requirements / Qualifications:
  • BS degree preferably in an Engineering, Biotechnology, Biological/Physical sciences or equivalent.
  • Minimum of 7 years experience in a GMP biopharmaceutical manufacturing environment in Technical Operations and/or Quality.
  • Strong working knowledge and interpretation of FDA, EMA, local regulations and guidelines, Good Distribution Practices, ICH guidelines and industry best practice.
  • Experience supporting authoring/reviewing/approving technical studies
  • Experience leading and participating in investigations into manufacturing and analytical deviations and determination of product impact, root cause, and corrective and preventive actions.
  • Experience with performing technical assessment of changes for potential impact to qualification/validation of processes, equipment, utilities, facilities, and systems.
  • Capability of collaboratively engaging with CMO’s.
  • Experienced in all phases of biologics, gene therapy, and/or cell therapy drug development.
  • Demonstrated high personal and professional ethical standards.
  • Possesses excellent judgement with the ability to think and act quickly.  Must be able to identify creative solutions to complex technical problems.
  • Ability to interpret and relate Quality standards for implementation and review.
  • Ability to communicate clearly and professionally both in writing and verbally.
  • Strong organizational and project management skills with a track record fo meeting goals/objectives.
  • Strong experience with regulatory authority inspections, including FDA and EMA.
  • Travel may be required when appropriate (approximately 10%). 
  • Expert knowledge of cGMP compliance regulations and industry practices for US/Ex-US 
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About Bedford, MA

Explore exciting job opportunities in and around Bedford, Massachusetts! Located in Middlesex County, just a short drive from Boston, this charming town offers a perfect blend of suburban tranquility and urban convenience. With close proximity to historic sites like the Bedford Flag and the Minute Man National Historical Park, as well as a thriving arts scene showcased at the Higgins Art Gallery, job seekers can enjoy a rich cultural experience while advancing their careers. Indulge in delicious New England cuisine, catch a show at the nearby Merrimack Repertory Theatre, or cheer on the beloved Boston Red Sox at Fenway Park. Embrace the picturesque beauty of nature at nearby Bedford Center Park or take a stroll by the Concord River. Don't miss the chance to grow both personally and professionally in this vibrant and dynamic region!