Clinical Product Quality Lead

  • Dublin
  • Morgan Mckinley
Serving as the Quality representative on the CMC Team, this person will collaborate with various stakeholders to uphold quality standards, manage risks, and facilitate regulatory compliance. This role encompasses oversight of multiple clinical products across different formats and phases, with a focus on maintaining GMP standards and supporting clinical program objectives. The successful candidate will have minimum 8 years' experience in cGMP QA within the biotechnology, pharmaceutical or biopharmaceutical manufacturing sector with 5 years' experience in pre-clinical through commercial phases. Experience with review of market applications, INDs, supplements, regulatory documentation, working with contract manufacturers and laboratory organisations. Strong understanding of pharmaceutical drug product development and manufacturing processes. Bachelor's degree in science essential with prior experience in genomic medicines desirable Responsibilities Oversee quality aspects of clinical products, spanning various formats and stages from pre-clinical to commercial launch. Act as a Quality advocate and primary liaison for CMC program strategy teams, ensuring alignment and timely completion of quality-related tasks. Proactively manage quality risks associated with clinical products, communicating effectively with Senior Management. Provide Quality Assurance support for clinical manufacturing activities, ensuring compliance with industry standards and regulatory requirements. Lead Quality meetings to align on timelines, assess risks, and prepare for post-launch quality oversight. Develop release strategies for new products in collaboration with Qualified Persons (QPs). Review and assess significant deviations related to products, conducting thorough root cause analyses, and reporting, as necessary. Facilitate change controls affecting clinical products and support activities related to contract manufacturing and laboratory organizations. Serve as the Quality Subject Matter Expert (SME) for regulatory submissions and responses to regulatory agencies. Maintain supply chain maps and product specification file summaries, ensuring accuracy and completeness. Support integration efforts for acquired assets through business development activities. If this role is of interest, please 'apply now' or contact me for further information on 021 2300 300. Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative. BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES. #J-18808-Ljbffr