About Your New Employer: This Employer is a clinical-stage genetic medicine company with a broad pipeline of late-stage clinical programs supported by end-to-end manufacturing capabilities.
About Your New Job as a Senior QC Analytics Manager: Ensure day-to-day management of the QC analytical team, ensuring the laboratory is inspection ready and that any data generated is valid and in compliance with applicable internal and external cGMP requirements.Oversee the Quality Control department to support the quality control release and stability testing of gene therapy products and associated materials.Provide line management to members of the QC analytical team to contribute to the overall group objectives and development of staff.Develop and manage the site testing schedule to ensure testing is complete by the required timelines.Plan and assign work to the team to achieve the most efficient use of personnel and resources.Be responsible for running and maintaining the QC lab(s) to GMP compliance.Manage the stability program and ensure testing is complete within the required test windows.Support any incoming material testing to ensure adequate supply of materials.Ensure all quality events (Deviations, CAPA, OOS, etc.)
are investigated and closed in a timely manner.Review all analytical data generated within the QC analytical team.Organize and review testing with 3rd party collaborators.Support the development, qualification, validation, and implementation of analytical methods within QC.Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators.Contribute to cross-departmental activities and provide expert advice and technical input where needed.Ensure that any GMP documentation (e.g., Issues, CAPAs, Change Controls, BMRs & audit/inspection actions) within own area of responsibility is closed timely and in a RFT state.Monitor and achieve own and team KPIs, plans, targets, and objectives effectively.What Skills You Need to Succeed as a Senior QC Analytics Manager: 7+ years working in a Pharmaceutical/Biotech QC function within a sterile manufacturing site.Experience managing a team of people within a cGMP QC analytical environment.Degree in a relevant scientific discipline (or equivalent) or relevant experience.Understanding of GMP requirements, including legislation, guidelines, and requirements related to Gene Therapy, QC method qualification and validation, QC processes, equipment and systems, including Computer Systems, e.g., EU GMP requirements for Advanced Therapy Medicinal Products, EU/FDA GMP guidelines, EU Annex 1, EU Annex 11 & CFR Part 11, and ICH guidelines Q1-Q10.Good collaboration, communication, and conflict resolution skills.Experience in audit inspections.Good technical writing skills.Ability to work in a fast-paced environment is essential.What's on Offer for Candidates for a Senior QC Analytics Manager: Salary of up to 75k.Very attractive benefits package.Working in a state-of-the-art facility.Fantastic development opportunities.What's Next: Apply now by clicking the "Apply Now
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