Cmc Qa Associate

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.