Senior Quality Manager
2 days ago
Quality Excellence Matters
Job Overview:We are seeking a quality professional to lead our External Contract Manufacturer (ECM) partnerships and ensure they meet our quality requirements.
- Develop and maintain Quality Agreements between ECM and us
- Work with Product Quality and Design Quality to execute technical transfer activities to ECMs
- Manage Quality and Compliance related issues between ECM and us
- Participate in Health Authority inspections and audits of ECM to ensure successful inspection outcomes
- Act as Quality contact for assigned ECM partnerships
- Review and approve Annual Product Quality Review (APQR) reports for products manufactured at ECMs
- Escalate and manage ECM issues within the Field Action process
- Set and monitor quality system requirements to suppliers within the Finished Good and Contract Manufacturing space
- Perform Baxter batch release for product at ECM sites
- Execute SCAR management ensuring effective and timely closure
- Assess quality notifications from ECMs and determine if escalation to SCARs and NCR is needed
We are an equal opportunity employer that 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.
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