QA Manager and RP - GDP

Our client, a specialty biopharmaceutical company, is seeking a QA Manager and RP to join their team in Maidenhead, UK. This is a permanent role.

Job Role:

The Manager, International QA is responsible for the oversight of key contract manufacturing organizations, test labs and distributors. This role will be primarily responsible for ensuring GMP/GDP compliant procedures are in place to support the Company's international marketed product program.

Job Responsibilities:

• Responsible Person named on Wholesale Dealers Authorisation
• Oversee commercial CMOs, test labs, packagers and distributors in support of commercial supply of product to the EU and ROW
• Provide Quality review of documentation including batch records/CoAs, deviations, CAPA, complaints, change controls, OOS investigations, stability data etc. with accurate database management and metrics reporting.
• Act as the Quality representative for suppliers and conduct, facilitate or participate in audits and mock inspections as necessary.
• Provide guidance in the development of an EU Quality System including review of procedures and policies to ensure compliance with GMP/GDPs.
• Coordinate activities for inspection readiness cross functionally within the company.
• Participate in the development of responses to agency observations or deficiencies and ensure CAPAs are completed timely with appropriate effectiveness verification
• Facilitate and participate in risk assessments and execution of risk mitigation plans during commercialization of drug product from a quality perspective.
• Lead the Management Review process to identify and communicate significant quality systems or product issues to management and make recommendations for process improvements and the promotion of best practices
• Support regulatory submissions with provision of GMP documents.
• Providing relevant GMP/GDP training.
• Provide estimates for budget planning as needed to identify audits and travel requirements and other areas where financial resources are necessary.
• Reporting Line The Manager International QA will report to the Director International QA. The position has no direct reports.

Education and Experience:

• A minimum of a BS preferably in chemistry or life sciences.
• Minimum of 8 years of experience with increasing responsibility in bio/pharmaceutical, GMP/GDP related Quality environment.
• Experience acting as a Responsible Person.
• Experience conducting and reporting on audits of various GMP/GDP suppliers.
• Strong written and verbal communication skills, and analytical problem solving and conflict resolutions kills.
• Flexible, highly motivated, with strong organization skills and the ability to multi task. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.
• Ability to work independently and to make decisions based on experience.
• Effective interpersonal skills.
• Ability to travel internationally up to 30%.

To Apply:
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.