Quality Consultant (m / f / d)

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role, your work makes a positive impact on people around the world. You will 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 seeking a Quality Consultant (m/f/d) to support Baxters external contract manufacturers in Pharma (m/f/d), based in Bielefeld.

About this position :

This is an exciting role in our pharma quality team located in Bielefeld, Germany. You will support the quality governance of Baxter's third-party external contract manufacturers (ECMs). You will oversee ECMs located in Germany and support other ECMs within Baxter's global footprint.

Essential Duties and Responsibilities :

1. Act as the Quality contact for assigned 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. Collaborate with Design Quality to execute technical transfer activities to ECMs and support new product development and tech transfers for the pharma segment.
5. Manage Quality and Compliance issues between ECM and Baxter.
6. Participate in Health Authority inspections and Baxter audits of ECMs to ensure successful outcomes and maintain inspection readiness.
7. Perform quality risk assessments, develop mitigation actions, and follow up on CAPA implementation. Monitor quality and process improvement initiatives at ECMs.
8. Define metrics for new ECMs, monitor, and report on quality performance.
9. Ensure timely change implementation, deviation/investigation reviews, complaint investigations, and CAPA closures at ECMs. Review and approve APQR reports for Baxter products manufactured at ECMs.
10. Escalate and manage ECM issues within the Baxter Field Action process.
11. Collaborate with Baxter employees across global sites to assess the impact of ECM Supplier Notices of Change (SNC).
12. Perform Baxter batch release for products at ECM sites.
13. Set and monitor quality system requirements with suppliers in finished goods and contract manufacturing.
14. Execute SCAR processes and ensure effective closure.

Qualifications :

• Strong analytical skills with a proven track record in supporting product quality impact assessments and lot disposition decisions.
• Effective communication skills, proficiency in English (other languages beneficial).
• Experience with medical product quality and compliance management systems.
• Ability to make routine and some less routine decisions independently.
• Flexibility and adaptability across projects.
• Strong quality orientation with knowledge of pharmaceutical/regulatory standards (FDA cGMP, ICH, ISO 13485, ISO 9001, etc.).
• Experience in product lifecycle management (preferred).
• Knowledge of business practices, policies, and technology trends.
• Excellent teamwork, facilitation, and project management skills.
• Willingness to travel up to 10%.

Education and Experience :

• BSc in science or engineering.
• At least 7 years of experience in Quality, Manufacturing, Engineering, or related fields.
• Experience in the medical industry, particularly pharmaceuticals or combination products.
• Experience with root cause analysis, CAPA, FMEA, 8D, 5WHY, and statistical tools.
• Proficiency in Microsoft Office, Trackwise, Tableau, and advanced statistical packages.

What we offer you

We offer professional training, competitive remuneration, excellent social benefits, a company pension scheme, share plan, 30 days of vacation, and additional insurance options.

Additional Information

For more details, contact Sebastian Lange via email.

Baxter supports flexible working arrangements in accordance with local laws, including minimum onsite days as needed for collaboration.

Reasonable Accommodations

Baxter is committed to providing reasonable accommodations for individuals with disabilities. Please contact us if you require assistance during the application or interview process.

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