CMC QA Associate Overview • The CMC QA Associate will oversee quality assurance activities for gene therapy programs, ensuring compliance with cGMP regulations and industry standards. • Collaborate with cross-functional teams, including Technical Operations, Regulatory Affairs, and Manufacturing, to maintain and improve quality processes. • Provide quality oversight for clinical and commercial product lifecycle activities, ensuring adherence to global regulatory requirements. • Review and approve batch records, deviations, and other quality systems to ensure product quality and compliance. • Support process validation activities, including performance qualifications, mixing validation, and impurity studies. • Author and review regulatory submissions, responses, and quality system records throughout the product lifecycle. • Engage with contract manufacturing organizations (CMOs) to ensure quality standards are met and maintained. • Promote a culture of operational excellence and continuous improvement within the quality management system. • This role is onsite, providing hands-on collaboration and oversight at the Bedford facility. CMC QA Associate Key Responsibilities & Duties • Lead quality assurance activities for cross-functional CMC sub-teams, ensuring compliance with regulatory standards. • Provide oversight for process validation protocols, including mixing validation and extractable studies. • Review and approve technical transfer plans, reports, and associated deliverables. • Support batch disposition and release activities for clinical and commercial products. • Ensure GMP processes are implemented within the Quality Management System for lifecycle management. • Collaborate with CMOs to ensure quality standards and regulatory compliance are maintained. • Author and review regulatory dossiers, strategizing responses to agency queries. • Support investigations into manufacturing deviations, determining root causes and corrective actions. • Communicate effectively to promote quality and operational excellence across teams. CMC QA Associate Job Requirements • Bachelor of Science degree in Engineering, Biotechnology, or Biological/Physical sciences. • Minimum of 9 years of experience in GMP biopharmaceutical manufacturing, preferably in Technical Operations or Quality Assurance. • Strong knowledge of FDA, EMA, ICH guidelines, and industry best practices. • Experience with process validation, manufacturing investigations, and regulatory submissions. • Proficient in managing quality systems, including deviations, CAPA, and change controls. • Demonstrated ability to engage collaboratively with CMOs and cross-functional teams. • Expertise in biologics, gene therapy, and cell therapy drug development. • Strong organizational and project management skills with a focus on meeting objectives. • Willingness to travel as needed, approximately 10% of the time.