This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
We are currently searching for a Quality Consultant (m/f/d) supporting Baxter’s external contract manufacturers, Pharma (m/f/d) based in Bielefeld.
About this position:
Exciting role in our pharma quality team located in Bielefeld, Germany that will support the quality governance of Baxter third party external contract manufacturer’s (ECM). You will have responsibility of oversight of ECMs located Germany and will also support other ECMs within Baxter’s global footprint.
Essential Duties and Responsibilities:
1. Act as Quality contact for assigned External Contract Manufacturer (ECM) partnerships.
2. Work with new ECM partners to ensure they meet Baxter quality requirements.
3. Assist with the negotiation, development, and maintenance of Quality Agreements between ECM and Baxter.
4. Work with Design Quality to execute technical transfer activities to ECMs. Support Quality Lead on new product development and tech transfers for pharma segment.
5. Manage Quality and Compliance related issues between ECM and Baxter.
6. May participate in Health Authority inspections and Baxter audits of ECM to ensure successful inspection outcomes and maintain a constant state of inspection readiness at ECM sites.
7. Perform quality risk assessments; develop mitigation actions and follow-up on CAPA implementation and monitor quality/process improvement initiatives at the ECM.
8. Define applicable metrics for new ECMs. Monitor and report quality performance metrics for established ECMs.
9. Ensure timely change implementation, deviation/investigation review, complaint investigations, and CAPA closures at the ECM. Review and approve Annual Product Quality Review (APQR) reports for Baxter products manufactured at ECMs
10. Escalate and manage ECM issues within the Baxter Field Action process
11. Work with Baxter employees across multiple global sites and functions to assess the impact of an ECM Supplier Notice of Change (SNC).
12. Perform Baxter batch release for product at ECM sites.
13. Set and monitor quality system requirements to suppliers within the Finished Good and Contract Manufacturing space.
14. Execute SCAR and management ensuring effective and timely closure.
Qualifications:
15. Strong analytical skills and a proven track record in solving problems to support product quality impact assessments and lot disposition (release/reject) decisions.
16. Effective communicator internally and externally at all levels; excellent written, oral, and interpersonal communication and presentation skills (English is required. Other languages beneficial).
17. Experience with medical product quality and compliance management systems.
18. Ability to make routine and some less routine decisions independently.
19. Demonstrates flexibility and the ability to shift gears between projects comfortably.
20. Strong quality orientation required. Knowledge of pharmaceutical and/or combination product regulations, e.g., FDA cGMP, ICH, pharmacopoeia, Eudralex, ISO 13485, ISO 9001 other global or regional equivalent
21. Experience in product lifecycle management (preferred)
22. Knowledge of Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business and organization
23. Collaboration and Teamwork: Good communications, facilitation, coordination and team skills
24. Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions
25. Ability to manage the Quality relationship with assigned key suppliers/stakeholders
26. Willingness to travel (up to 10%)
Education and/or Experience:
27. BS in science or engineering. 7+ years’ experience in Quality, Manufacturing, Engineering, or related field.
28. Seven years of directly related experience within the medical industry. Pharmaceutical and/or combination product experience preferred.
29. Project management experience preferred
30. Manufacturing experience is desired in finished goods (medical device, drug, and biologics) and contract manufacturing
31. Experience in root cause analysis, corrective and preventive action methods; Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA / 5WHY etc.
32. Experience with Microsoft Office, Trackwise, Tableau and advanced statistical /process packages
What we offer you
As an internationally active company, we offer you professional training opportunities and fair remuneration with above-average social benefits, a company pension scheme, a share plan for employees, 30 days vacation plus special leave, and additional insurance is a matter of course, for us.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
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