Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
Location/Division Specific Information
Fisher Clinical Services GmbH is a subsidiary of Thermo Fisher Scientific Inc. and is a market leader in Clinical Supply Chain Management Services and Clinical Supplies for patients worldwide.
You can find out more about our location in Weil am Rhein and Rheinfelden here:
Discover impactful Work
Under the direction of the Director Quality, the Manager Quality Assurance (QA) is responsible for overseeing the Quality Assurance team at the Weil am Rhein and Rheinfelden sites, ensuring that all quality systems and compliance standards are maintained. The role also involves leading compliance initiatives and maintaining continuous oversight across departments, aligning quality processes with both current and emerging regulations.
This role provides strategic leadership in driving long-term quality initiatives and support in shaping the overall quality culture across the organization. The QA Manager includes full responsibility for the entire audit program, managing various types of audits including customer, internal, and regulatory audits, and acting as the audit host manager for these audits and inspections in Germany
A Day in the Life
Responsibility for the QR Approver Team, which includes managing all aspects related to investigations, CAPAs, and ensuring compliance in quality-related decisions. Furthermore,
Oversight of the Batch Record Review process post-approval, ensuring adherence to EU GMP and local regulatory requirements, and serves as the deputy to the Responsible Person (RP) for GDP for the German sites.
Strategic leadership to continuously enhance the quality management framework and strengthen regulatory compliance.
Acting as the primary point of contact for quality-related client matters and serves as a key decision-maker in the absence of the Director Quality and participates in management meetings as needed.
Quality Improvement Project Leadership:
1. Lead and support the Quality Assurance team to meet regulatory and business requirements at FCS Germany sites.
2. Serve as the main point of contact for clients, participating in regular meetings and providing client-specific KPIs.
3. Compliance Management:
4. Ensure regulatory compliance and continuous oversight across departments.
5. Oversee the CAPA (Corrective and Preventive Actions) process, including feedback, implementation, and tracking.
6. Maintain and review GlobalTrackWise events.
7. Act as the deputy for the Responsible Person (RP) for Good Distribution Practice (GDP).
Strategic Leadership:
8. Oversee the entire audit program, including customer, internal, and regulatory audits.
9. Ensure proper investigation and resolution of quality incidents and deviations.
10. Oversee the Batch Record Review process post-approval.
11. Lead quality improvement initiatives and set long-term strategic goals.
12. Serve as the main point of contact for quality-related client matters and provide quality metrics.
13. Plan and execute internal and external audits, and follow up on audit events.
14. Analyze data to identify improvement areas and implement quality-enhancing changes.
15. Escalate major quality issues to management.
16. Collaborate with other departments to enhance quality standards and ensure cohesive practices.
Keys to Success
Education:
17. University degree in Pharmacy is preferred
Experience:
18. GxP training or experience
19. Demonstrated ability to perform detail-oriented tasks
20. GMP QA and QC experience within packaging and distribution
21. Root cause analysis training and investigation report writing
22. Compliance Expertise: In-depth understanding of regulatory requirements, including EU GMP and GDP, and the ability to ensure compliance across multiple functions.
Knowledge, Skills, Abilities
23. Compliance Expertise: In-depth understanding of regulatory requirements, including EU GMP and GDP, and the ability to ensure compliance across multiple functions.
24. Proficiency in Microsoft Office Suite (Word, Excel, GlobalTrackWise, eDMS).
25. Strong written and verbal communication skills, with the ability to effectively communicate with clients and lead quality teams. Emphasis on internal communication skills is crucial, especially when working cross-functionally, to promote a strong quality culture and effective collaboration.
26. Strong administrative and organizational skills.
27. Fluency in German and English (B2 or higher level, both written and spoken).
28. Proven ability to work effectively in team settings, lead diverse groups, with demonstrated team leadership/management experience, and excellent problem-solving skills.
What we offer
29. Employment with an innovative, future-oriented organization
30. Outstanding career and development prospects
31. Company pension scheme and other fringe benefits
32. Exciting company culture which stands for integrity, intensity, involvement and innovation