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.
The role
The Senior Quality Assurance Manager is responsible for assuring conformity of the manufacturing processes and products to the quality requirements (procedures and regulations) manufactured at Lessines site.
Essential Duties & Responsibilities
1. Supervising all activities at plant level as related to Operational Quality, Complaints and Release.
2. Assure escalation of any potential FA and gather data to assist FA process.
3. Support product release by ensuring timely review and investigation of deviations related to the manufacturing process.
4. Support NCR and CAPA process: root cause identification and continuous improvement.
5. Ensure timely documentation and closure of NCR, CAPA and complaint records.
6. Ensure timely investigation and response to ICARs.
7. Review and assess process and documentation change requests.
8. Participate in internal and external quality system audits conducted by the corporate or regulatory agency representatives.
9. Collaborate with ICO partners for projects or issue resolution (intracompany).
10. Support quality systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives.
11. Ensure training is completed for area of control.
12. Perform reporting of KPI as applicable (CAPA review board, Management Review…)
13. Support 6s program.
14. Response Quality on the shopfloor during visits / audits.
15. Manage, support and develop the Operational Quality, Complaints and Release teams.
16. Monitor KPI and take action to meet target for the department
Qualifications
17. Bachelor’s degree in a relevant scientific discipline; advanced degree preferred
18. Minimum of 10 years of experience within the pharmaceutical industry, with progressively increasing levels of responsibility
19. Minimum 5 years of experience in people management
20. Fluency in French and English is a must
21. Being recognized as Qualified Person, as defined in the for Medicinal products and as defined in for veterinary medicinal products is an added value
22. Problem-solving and analytical skills
23. Critical and inquisitive mind
24. Excellent communication and presentation skills
25. Resistant to stress & demonstration of flexibility in times of change