Associate Manager, Quality ECM

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.

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 maintainance of Quality Agreements between ECM and Baxter.
• Cordination within team for routine activities and work management.
• Having good managerial skill for effective team management.
• Having problem solving ability to resolve the quaeries and concern of team mates.
• Work with Product Quality and Design Quality to execute technical transfer activities to ECMs.
• 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
• Work 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 management ensuring effective and timely closure. Assess quality notifications from ECMs and determine if escalation to SCARs and NCR is neededImprove/develop quality systems at selected suppliers for QMS and compliance improvement
• Support Supply Chain, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.

Equal Employment Opportunity

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

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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