PW-6550 Senior Manager or Associate Director Global QA
Closing Date: 23 Oct 16
Salary (£): Competitive
This is an opportunity to ensure high quality consistency of products in both development and commercial stages and contribute to QA support for commercial readiness. You will monitor the quality risk for QA of EU marketed products in terms of GMP/ GDP or be focused on the Quality systems side depending upon your experience, as well as work with EU manufacturing sites and Affiliates.
Global organisation – top 20 pharma
Excellent career development opportunities
Fantastic, modern offices
Specific responsibility focus will be determined by candidate level and type of experience (i.e. whether more focused on GMP Quality Operations or Quality systems)
- Monitor the quality risk for Quality Assurance of European marketed products in terms of GMP and GDP and to lead and supervise Quality Assurance of such Products including Development Products, based on Quality Systems of the sites and departments. Products include Active Pharmaceutical Ingredients, Investigational Medicinal Products and Authorized Medicinal Products.
- Coordinate and cooperate Quality Assurance Activities with European manufacturing sites and EU Region Affiliates communicating with GQA and other regional QA.
- Develop relationships with key stakeholders (including Legal, Operations, Regulatory and Affiliates).
- Monitor new developments in external Quality Assurance requirements, EMEA, ICH etc. And provide the training to relevant departments.
- Assess the consistency of the Quality System in the Plants and Affiliates by conducting internal audits.
- Act as a liaison with RAE, R&D and external bodies (European Health Inspectorates) to represent group on QA/QC issues and maintaining QA/QC requirements for standards within Production.
- Advise European plants and affiliates about the quality system to comply with QA requirements.
- Participate in regular meetings with GQA.
- Review the audit and inspection of plants by Health Authority, external consultant and GQA. Take part in special audit of the plants, contract manufacturers and affiliate operations.
- Plan EMEA Region QA conferences and ensure deliverance of value adding agenda and management of meeting outcomes
- Coordinate and execution of training programs to QA members and responsible staff for cross functional quality processes.
- Review and approve Technical Agreements for European products.
- Provide Advice to GQA for the improvement of global QA systems and procedures.
- Regional and Local product quality review.
QUALIFICATIONS / EXPERIENCE REQUIRED:
- Substantial relevant experience.
- Quality Assurance and Quality Control experience as a pharmacist or equivalent qualification in European Pharmaceuticals.
- Manufacturing environment experience is essential for a GMP Quality operations focused role
- QA systems experience for a more systems focused role
- Auditing experience.
- Knowledge of GMP and QA systems for either area of role focus.
- Knowledge of European Directives related to Pharmaceutical Industry.
- Multi regional experience
Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.
For a confidential discussion please telephone Anette Gillan at AXESS Limited on 020 8560 2300. To apply, please send your CV to firstname.lastname@example.org quoting reference PW-6550
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