Sr Quality Assurance Manager

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

• Supervising all activities at plant level as related to Operational Quality, Complaints and Release.

• Assure escalation of any potential FA and gather data to assist FA process.

• Support product release by ensuring timely review and investigation of deviations related to the manufacturing process.

• Support NCR and CAPA process: root cause identification and continuous improvement.

• Ensure timely documentation and closure of NCR, CAPA and complaint records.

• Ensure timely investigation and response to ICARs.

• Review and assess process and documentation change requests.

• Participate in internal and external quality system audits conducted by the corporate or regulatory agency representatives.

• Collaborate with ICO partners for projects or issue resolution (intracompany).

• Support quality systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives.

• Ensure training is completed for area of control.

• Perform reporting of KPI as applicable (CAPA review board, Management Review…)

• Support 6s program.

• Response Quality on the shopfloor during visits / audits.

• Manage, support and develop the Operational Quality, Complaints and Release teams.

• Monitor KPI and take action to meet target for the department

Qualifications

• Bachelor’s degree in a relevant scientific discipline; advanced degree preferred

• Minimum of 10 years of experience within the pharmaceutical industry, with progressively increasing levels of responsibility

• Minimum 5 years of experience in people management

• Fluency in French and English is a must

• Being recognized as Qualified Person, as defined in the Directive 2001/83/EC for Medicinal products and as defined in DIRECTIVE 2001/82/EC for veterinary medicinal products is an added value

• Problem-solving and analytical skills

• Critical and inquisitive mind

• Excellent communication and presentation skills

• Resistant to stress & demonstration of flexibility in times of change

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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