Director Research - Friesoythe, Deutschland - Vet Pharma Friesoythe GmbH

Beschreibung

Join our esteemed pharmaceutical company based in Friesoythe, committed to advancing healthcare through innovation and quality. We specialize in the research, development, and distribution of life-saving medicines and vaccines.

As a vital member of our team, you'll play a crucial role in ensuring compliance with global regulatory standards and driving continuous improvement in quality and operational excellence.

As the Lead of the Site Quality Unit you will be responsible for a team of about 85 employees.

Aditionally, the position is part of the Site Leadership Team and provides strategic Quality direction to the Site team (about 400 People) to ensure compliance of manufacturing, testing and release with all applicable regulations including FDA and EU GMP requirements.

Knowledgeable of GMP compliance and conversant with domestic and foreign regulations compendia governing plant operations – FDA experience required
Ability to plan, prioritize, and effectively manage projects and programs independently
Ability to work effectively in a team environment and todrive changes in the team
Technical / analytical data comprehension
German proficiency


Quality and Compliance:
Provide strategic Quality direction to the site team
Ensure all GMP compliance activities are coordinated, prioritized, and completed in accordance with approved procedures
Remain abreast of and assure GMP compliance with applicable worldwide regulatory standards
Responsible for the Quality management systems (documentations, deviations, complaints, CAPA, change controls, audits, PQR, Quality supplier management, Quality Risk Management, TQA...)
Ensure the right Quality Metrics are measured at the right tier levels including Site Quality Council to oversee the quality systems and maintain the site in a state of control and permanent inspection readiness
Provide quality expertise for capital project initiatives and ongoing project work
Represent Quality on cross-functional teams to ensure alignment to our Policies & Guidelines and regulatory requirements

Organizational and People Development:
Ensure continuous development of talent through coaching and development plans for the Quality talents
Ensure compliance to all established safety procedures and practices and completion of all required safety training


Our Benefits:
Attractive compensation package (13 monthly salaries plus target bonus)
Company pension plan
Vacation allowance (1.Employee benefits
Company bike / bicycle leasing
Additional payment for Hansefit (Fitness Membership)