CMC QA Associate

The CMC QA Consultant will report to the 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). 

• Review and approve batch records, CC, deviations, and other quality systems*
• 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

Responsibilities:

• 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, Change Controls, Deviations, and other quality systems as needed*
• Support batch disposition and release activities internally and at external partners*
• 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 records (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 9 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 supporting manufacturing operations in a Quality Assurance role*
• 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 CMOs.*
• 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 of 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