Description1. Act as the Quality contact for assigned CMO partnerships.
2. Work with new CMO partners to ensure they meet Baxter Supplier Quality requirements.
3. Negotiate, develop, and maintain Quality Agreements between CMO and Baxter.
4. Assist with technical transfer activities to contract manufacturing organizations.
5. Manage Quality and Compliance related issues between CMO and Baxter.
6. May participate in Health Authority inspections and Baxter audits of CMO to ensure successful inspection outcomes and maintain a constant state of inspection readiness at CMO sites.
7. Perform quality risk assessments; develop mitigation actions and follow-up on CAPA implementation and lead quality/process improvement initiatives at the CMO.
8. Monitor and report quality performance metrics.
9. Ensure timely change implementation, deviation/investigation review and CAPA closures at the CMO.
10. Work with Baxter employees across multiple global sites and functions to assess the impact of CMO changes and/or risks.
11. Perform Baxter batch releases for product at CMO sites.
• Strong quality orientation required. Knowledge of cGMP, global regulatory guidelines, and validation practices.
• Strong analytical skills and a proven track record in solving problems to support product quality impact assessments and lot disposition (release/reject) decisions.
• Effective communicator internally and externally at all levels; excellent written, oral, and interpersonal communication and presentation skills (English is required. Other languages beneficial)
• Experience with medical product quality and compliance management systems
• Ability to make routine and some less routine decisions independently.
• Demonstrates flexibility and the ability to shift gears between projects comfortably.
• Ability to travel domestically or internationally.
Education and/or Experience:
• BS in science or engineering. 5+ years experience in Quality, Manufacturing, Engineering or related field.
• Project management experience preferred.
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.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.