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Director, Medication Delivery CAPA Process & Execution
Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.Provide divisional leadership and oversight in ensuring compliant and effective CAPA execution in Medication Delivery (MD).
Assess and improve the consistency, quality, and timeliness of MD divisional CAPA execution through implementing and maintaining effective CAPA monitoring systems and review mechanisms.
Interface with senior management, peers, and subordinates to identify required CAPA system and process improvement initiatives across the division. This includes but is not limited to the remediation of CAPA system and process deficiencies noted in audits and/or inspections.
Remain conversant with the appropriate regulations, laws and standards to maintain MD CAPA process compliance, and to provide up to date guidance and training.
Interface with auditors/inspectors relating to the MD CAPA system and process.
Grow and maintain team of CAPA experts/mentors to provide divisional guidance on expected CAPA execution.
Develop and deliver CAPA training to ensure MD divisional knowledge of CAPA requirements, process and individual responsibilities is known and maintained.
- Bachelors degree required, Masters degree strongly preferred.
- 10 years minimum of experience in Quality function in a regulated medical industry.
- 5 years minimum of CAPA managerial experience in a regulated medical industry.
- Proven ability to drive change across organization utilizing strong relationship management skills and ability to influence in a matrix environment at multiple levels.
- Experience interacting with FDA & ISO regulatory auditors/inspectors as pertaining to CAPA
- Strong organizational and communication skills, with a demonstrated ability to recruit, motivate, and guide teams of professionals.
- Strong knowledge and understanding of applicable CAPA system regulations and standards (e.g. 21CFR 820.100, ISO9001, ISO13485).
Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
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