Description:
Bristol-Myers Squibb Services Unlimited are responsible for Clinical Supply Chain Quality including Certification and Sponsorship of new and in-flight clinical trials destined for Europe and beyond.
Clinical Supply Quality is seeking to recruit on a permanent contract a Manager, Clinical Supply Chain Quality, to support activities. Reporting to the Director of Clinical Supply Quality, the Manager will provide QA support to Qualified Person (QP) for Investigation Medicinal Product (IMP) supplies shipped through the EU Central Warehouse (EUWH) and provide QA support and oversight to Clinical Supply Logistics.
Key Duties And Responsibilities
- Compilation and review of batch release dossiers for Qualified Person certification of IMP to clinical trials.
- Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File.
- Generates and maintains Product Specification Files (PSF) for IMP.
- Provides QA support and oversight of packaging and labeling operations for IMP.
- Support the generation and ongoing maintenance of Quality Agreements.
- Provides Quality Assurance support in the Use Date Extension process.
- Provides Quality Assurance oversight and support (GMP/GDP guidance and training) for CSO Logistics (EMEA and Asia)
- Supports in a timely manner, investigations of non-conformances and quality incidents as QA. Resolves and documents in the Quality Management System.
- Conducts appropriate follow-up, as required. Tracks deviation, investigations and CAPAs;
- Generate and complete QA review of supplier/customer qualification documentation for the Responsible Person (RP). Ensure supplier/customer qualification and re-qualification is complete within required timelines.
- Provide support to Health Authority inspections and internal audits as required.
- Prepares and reviews procedural documents.
- Complete Change control assessment and CAPA evaluation/CAPA close-out
- Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
- Support OPEX programs and champion continuous quality improvement initiatives.
Qualifications, Knowledge and Skills Required:
- The successful candidate will hold a BSc in Science or related discipline, with relevant QA or related experience in a Pharmaceutical environment.
- The candidate should hold a minimum of 3 years experience in a GMP/GDP environment.
- A clear understanding of cGMP and GDP requirements for the manufacture and distribution of medicinal products.
- The candidate should also be open to travel (up to 10%) in support of their role.
- The Manager will be required to work on his/her own initiative in addition to working as part of a team.
- The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication, presentation and critical thinking skills are essential.
- The successful candidate must demonstrate excellent time management & organisational skills along with a proven ability to multi-task.