Senior Manager Quality Assurance (GDP)

Role: Senior Manager Quality Assurance (GDP)  

Location: Remote

Type: Permanent

Salary: Competitive in line with skills and experience

For one of Planet Pharma’s rapidly expanding clients we urgently seek a talented Senior Quality Assurance Manager to join on a permanent basis. In this role you will be responsible for developing, implementing and maintaining global quality assurance strategy and supporting systems and compliance meet EU standards.

Responsibilities

• Plan QA goals and objectives focusing on product quality, continuous improvement and compliance to applicable regional and global agencies and standards (e.g., FDA QSR, ISO 13485)
• Oversee all daily QC operations including oversight of product release, review and approval of change controls, and development of reporting and corrective action plans for deviations and observations
• Working with EU Qualified Person and EU, CH, and UK Responsible Persons on interactions with health authorities including product release, preparation of license applications, participation in inspections/audits and facilitation of responses for any observations
• Manage the development, negotiation, and maintenance of contractual relationships with 3rd party quality related vendors

Requirements

• At least 5 years of QA/QC experience in Quality Assurance within a manufacturing environment, pharmaceutical industry. (Biologics preferred)
• Experience across EMEA
• Experience interacting with regulatory agencies in within EMEA
• Proven experience with European Goods Distribution Practices (GDP)
• Demonstrated knowledge of Quality Assurance in a global or at least regional pharmaceutical environment, and of Quality System Regulations and/or ISO 13485

To Apply

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0)20 3928 6631 or email on mowusu-ansah@planet-pharma.co.uk 

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age. Planet Pharma is an Employment Business providing Global Staffing services.