Quality Consultant (m/f/d)

Overview

Quality Consultant (m/f/d) at Baxter International Inc. Supporting Baxter’s external contract manufacturers and Pharma (m/f/d) based in Bielefeld, Germany.

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 manufacturers (ECM). You will have responsibility for oversight of ECMs located in Germany and will also support other ECMs within Baxter’s global footprint.

Essential Duties and Responsibilities

• Act as Quality contact for assigned External Contract Manufacturer (ECM) partnerships.
• Work with new ECM partners to ensure they meet Baxter quality requirements.
• Assist with the negotiation, development, and maintenance of Quality Agreements between ECM and Baxter.
• Work with Design Quality to execute technical transfer activities to ECMs. Support Quality Lead on new product development and tech transfers for pharma segment.
• Manage Quality and Compliance related issues between ECM and Baxter.
• 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.
• Perform quality risk assessments; develop mitigation actions and follow-up on CAPA implementation and monitor quality/process improvement initiatives at the ECM.
• Define applicable metrics for new ECMs. Monitor and report quality performance metrics for established ECMs.
• 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.
• Escalate and manage ECM issues within the Baxter Field Action process.
• Collaborate with Baxter employees across multiple global sites and functions to assess the impact of an ECM Supplier Notice of Change (SNC).
• Perform Baxter batch release for product at ECM sites.
• Set and monitor quality system requirements to suppliers within the Finished Good and Contract Manufacturing space.
• Execute SCAR and management ensuring effective and timely closure.
• Drive improvements for ECM processes.

Qualifications

• Strong analytical skills and a proven track record in solving problems to support product quality impact assessments and lot disposition decisions.
• Effective communicator internally and externally at all levels; excellent written, oral, and interpersonal communication and presentation skills (Proficient in English and German).
• Experience with medical product quality and compliance management systems.
• Ability to make routine and some less routine decisions and drive for solutions independently.
• Demonstrates flexibility and the ability to shift gears between projects comfortably.

Education and/or Experience

• BS in science or engineering. 7+ years’ experience in Quality, Manufacturing, Engineering, or related field.
• Seven years of directly related experience. Pharmaceutical and/or combination product experience preferred.
• Project management experience preferred.
• Manufacturing experience in finished goods (drug, and biologics) and contract manufacturing.
• Experience in root cause analysis and CAPA methods; familiarity with quality tools such as 6-sigma / 8-D / FMEA / 5WHY, etc.
• Experience with Microsoft Office, Trackwise, Tableau and advanced statistical/process packages.

What we offer you

As an internationally active company, we offer 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 as standard.

For further information, please reach out to Sebastian Lange via E-Mail:

Workplace policy

Baxter is committed to supporting flexible workplace needs. The policy includes a minimum number of days onsite. The policy is subject to local laws and business needs.

Equal Employment Opportunity

Baxter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you need an accommodation for any part of the application or interview process, please let us know with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Seniorities and Employment Type

• Seniority level: Mid-Senior level
• Employment type: Full-time

Job function and Industries

• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, Hospitals and Health Care

Referrals increase your chances of interviewing at Baxter International Inc. by 2x

Locations vary; Aachen/Bielefeld/Cologne Bonn Region, Germany, with posted roles and salary ranges in EUR.

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