Quality Systems & Compliance Supervisor

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.

About the role

As Quality Systems & Compliance Supervisor you act as the QS Expert and Process Owner for the following QS elements: Nonconformities, Change Controls, CAPA Review Board, Management Review and Supplier Quality Processes. You are responsible for forums, advice on site quality systems (e.g. CAPA Review Board, governance board, change control committee).

You coordinate the implementation of quality systems processes to comply with regulations, Baxter Global and local procedures and participate in the implementation and coordination of quality improvement projects and initiatives

You lead, supervise and coach your team to achieve the required objectives.

What you will be doing

• Anticipate problems, analyze different opportunities and make decisions thoughtfully to achieve objectives

• Develop your team and contribute to its performance

• Contribute to the development of the organization's general objectives and goals

• Lead teams in analyzing problems and ensuring the implementation of actions to avoid recurrence

• Participate in the implementation of projects

• Use in-depth knowledge of professional standards, tools and methods to manage daily work independently

• Propose suggestions for process improvement (safety, quality, performance)

• Collaborate with worker representatives

• Provide the necessary support during Security Aspect audits

• Lead the dynamics of takeover bids and safety observations for him and his team

• Ensure the analysis of first aid and accidents as well as the implementation of actions

• Respect and enforce the rules of good manufacturing practices (GMP) such as hygiene, dressing, behaviour, etc. as well as documentation (GDP)

• Keep processes under control to produce right the first time

• Document non-conformities according to the existing process

• Collaborate with Quality departments for any deviations

• Execute the planning within the allocated budget and participate in the development of budgets

• Participate in regulatory inspections, internal/local and external audits

• Ensure expected performance (compliance, efficiency and compliance with party requirements

• stakeholders) of quality systems processes (NCR/SNCR)/Capa & Change Control (CCR)

• Represent the site in global and regional meetings (Site Governance Council and Change Control Board) and act as a subject matter expert” Owner of NCR / SNCR, CAPA and CCR

• Prepare the Quality Management Review and follow up on the site’s quarterly Quality Management Review

• Identify and implement improvement opportunities

• Manage supplier data in the Baxter Supplier Management System (SQLM) and approve supplier data for specifications

• Carry out supplier audits (lead auditor or co-auditor)

• Send and approve SCAR (Supplier Corrective Action Report) as well as RAM (Risk Action Mitigation), ensure deadlines are met and follow up on supplier change notification (SNC)

• Project management (Quality or Production with quality impact), A3 QC Compliance

• Approve qualification reports and periodic review of chemistry laboratory equipment as well as related IT systems.

• Determine the qualification schedule in collaboration with users and according to needs

• Support NCR investigations and the implementation of CAPA and change control in collaboration with the chemistry laboratory managers

• Ensure EIRAs are updated

Your Profile

• Master’s degree or equivalent in chemistry, engineering, pharmaceutical sciences or related scientific field is required.
• Minimum of 3-5 years of experience in a role related to Quality (validation engineer, QA generalist, QA project manager, etc.) in the food industry, biotechnology or pharmaceutical industry
• Minimum 3-5 years’ experience managing people.
• You have experience of leading a team of experts and enjoy supporting, mentoring, and developing team members.
• Delivers dedicated timelines.
• Excellent written and verbal communication, presentation, and facilitation skills· Strong negotiation skills and significant experience in interacting with regulatory authorities
• Risk identification and problem-solving skills
• Demonstrated ability to lead, mentor, and develop others for future growth and development
• In-depth knowledge of HLS ISO standards (ISO 9001 or 22000), ISO 13485, cGMP, Eudralex, CFR
• Proven track record of successfully managing and implementing quality systems initiatives, including process improvements
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have English and French written and oral communication skills adequate to communicate with other team members.
• Strong leadership, communication, and interpersonal skills, with the ability to effectively collaborate and influence stakeholders at all levels of the organization.

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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