Senior Manager/ Associate Director Product Quality Management

Our client is seeking a candidates with strong experience and skills in Quality Assurance and GxP auditing, combined with sound experience in existing and new pharmaceutical technologies for a Senior Manager/ Associate Director fully on-site position. 

Responsibilities
As an Senior Manager / Associate Director PQM, GDP QA 

• Act as the primary QA responsible for Storage and Distribution activities related to commercial products. 
• Provide support for daily activities between Astellas and external third party logistics providers to ensure effective quality systems that meet GMP, GDP 
• Support the Supply Chain organization in QMS activities such as change control, review and approval of transportation deviations, management review, business review meetings with LSPs, review and approval of procedural documents.
• Travelling (typically 30%) will be on a global basis.

Qualifications

• Science based degree (pharmacy preferred). Demonstrated relevant further education achievement, e.g. eligibility for QP, Lean Sigma black belt and/or MBA qualification. Member of professional bodies and/or associations.
• 10 years of experience of Quality Assurance and Quality Control as a pharmacist or equivalent qualification in a European Pharmaceutical manufacturing environment.
• Previous experience in a GDP QA role is desirable.
• GxP Auditing experience and knowledge of GMP and QA systems.
• Problem solving skills and the ability to contribute to strategic planning, good communication skills, both written and spoken.