An internationally known biotechnology company has an opening for an Associate Director GDP job at their Berkshire office. The company has a strong reputation for developing innovative therapies for neurological diseases and employs approximately 7,000 people worldwide.
The Associate Director, Quality Assurance job holder will be accountable for oversight of Central Distribution warehouse as well as Commercial Logistics Operations. You will be responsible for definition and training on Quality Systems for Affiliate and Distribution, and to define Quality Systems for Affiliate and Distribution to meet cGDP, the company's global quality system requirements, relevant regulatory requirements and applicable licenses. You will also be responsible for overseeing the Expanded Access Program.
- QA supervision of the Central Distribution Warehouses and management of systems related to distribution
- Oversee from QA perspective all Commercial Logistics department activities and procedures
- Provide quality assurance oversight to Expanded Access Programs
- Coordinate Recall Process and Distributed Material Product related issues namely potentially falsified medicinal products
- Implement and maintain quality systems for QA Distribution and Affiliates
- Define and maintain Affiliate, IADQ and Logistics training program
Education and Experience:
- Minimum five years prior supervisory experience
- Minimum ten years experiences in pharmaceutical/biotech industry
- Excellent oral and written communication skills.
- Thorough knowledge of FDA, EU and ROW regulations and GLP, GDP, PV and GMP requirements.
- ASQ or other auditing certification a plus
- Proficiency in English, other languages are an asset
- Thorough understanding of regulations on Good Manufacturing Practices and Good Distribution Practices
- Knowledge of medical/biological and cold chain products
- Working knowledge in ISO Requirements / Certification Process
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Courtney Russell on +44 203 8141 315 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.