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Hyper Recruitment Solutions are currently looking for a Quality Director to join a leading Antibody Discovery company based in the Cambridge area. As the Quality Director you will be responsible for building and maintaining effective Quality Systems to ensure continued GxP compliance across the business.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Director will be varied however the key duties and responsibilities are as follows:
1. You will establish maintain and improve a Quality System (QMS) to manage all GxP activities, including safety, CMC, Pharmacology, Manufacturing and Clinical Activities. You will provide QA support to the business in Regulatory Filings and provide Vendor Management to all outsourced GxP activities (audit, CMC and safety).
2. The Quality Director will set up and manage a document/data management system for all R&D activities at the company HQ, in addition to providing GxP training programmes to support clinical/development projects in collaboration with regulatory and technical teams.
3. You will be the Subject Matter Expert for GxP compliance within the business and ensure that internal guidelines (Quality Management Systems) comply with GxP standards governing the development of a Biopharmaceutical Product.
4. It will be your responsibility to manage deviations, CAPA's, OOS/OOT at all CRO/CMO's in the Supplier Network and establish a culture of GxP compliance and continuous improvement (CI). This will involve developing Product Specification Files for new products.
To be successful in your application to this exciting opportunity as the Quality Director we are looking to identify the following on your profile and past history:
1. Proven experience in a Quality (QA) Focussed Bio-Pharmaceutical Leadership role with products at multiple development phases.
2. A working knowledge and practical experience with managing GxP compliance across a Global Network including CMO's, CRO's and Clinical Sites.
3. It would be advantageous to have experience with the design and successful implementation of a Pharmaceutical QMS and document/data management systems.
Key Words: Pharmaceutical Quality Assurance / External Quality / Management / Leadership / GMP / Customer Quality Assurance / Supplier Audit Schedule / Pharmaceutical QA / Quality Director / Senior Quality Assurance Manager / External Manufacturing / External Supply Chain / Biopharmaceutical / Pharmaceutical Supply Chain / Global Network / Vendor Management / Technical Leadership / Pharmaceutical Manufacturing / Project Management / End to End Supply Chain / Operational Excellence / Lean Manufacturing / Supplier Management / IRCA / QA / Compliance / Antibodies / mAb / Vector / Vaccines / CMC / Clinical / QA Manager / QA Director / Quality Director / Clinical Research / Clinical / Early Phase / R+D / Research and Development / Phase I / Phase II /Phase III / GCP / GLP /GxP
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.