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. The positions ensures also the operational needs for testing and releasing of products according to aligned schedule.
Requirements:
- Education: Pharmacist, or similar/equivalent scientific university degree in Chemistry or Biology
- Minimum ten (10) years of experience in Pharmaceutical or Vaccine Operations, Technology, and/or Quality Operations
- An understanding of aseptic techniques and GMP requirements for aseptic processing is mandatory
- Knowledgeable of GMP compliance and conversant with domestic and foreign regulations compendia governing plant operations – FDA experience required
- Knowledgeable of analytical, chemical, and microbiological methods, instruments, and IT systems
- Have strong leadership skills and demonstrated ability to motivate / mentor others to achieve results
- Excellent facilitation, verbal and written communication skills
- 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
Key responsibilities:
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 all testing and release activities including raw materials, components, intermediates and final product
- 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
- Monitor the performance of product and processes and recommend strategic direction for continuing enhancements to quality and customer service.
- Manage authority inspections and divisional audits for pre-inspection assessments
- Oversee and execute all applicable market actions and related investigations/regulatory notifications consistent with regulatory requirements
- Assure the preparation and timely submission Health Authority notifications to appropriate regulatory authorities
- Develop and implement the Site Annual Quality Plan and Quality Improvement Plans (as required)
- Provide quality expertise for capital project initiatives and ongoing project work
- Support production, quality and technology initiatives. Represent Quality on cross-functional teams to ensure alignment to our Policies & Guidelines and regulatory requirements
Organizational and People Development:
- Drive to ensure organizational fitness in terms of having the right capacity and capabilities avaialable
- Ensure continuous development of talent through coaching and development plans for the Quality talents
- Ensure a site culture of site culture of speaking up
- Embrace diversity and inclusion in both the Site Quality and across the plant site
- Ensure people within the organization have the appropriate GMP training
Financial
- Responsible to establish the yearly budget and to ensure adhearance.
- Drive Operational Excellence and continuous improvement to improve effectiveness and productivity of operational Quality tasks
Safety
- Ensure compliance to all established safety procedures and practices and completion of all required safety training
Our Benefits:
- Flex Time (37.5 hours/week)
- Attractive compensation package (13 monthly salaries plus target bonus)
- Company pension plan
- Vacation allowance (1.200