Quality Systems Manager

3 weeks ago

Alliston, Canada BAXTER Full time

**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.

**Your Role at Baxter**:
**GENERAL EXPECTATIONS**

The top two priorities for all Baxter Alliston employees are Safety and Quality:
**Safety**: Support our goal to achieve a “Zero Harm Environment”, by ensuring the safety of yourself and your co-workers through:

- following all safety procedures
- understanding potential hazards in your area
- wearing appropriate PPE
- reporting all incidents / near-misses / concerns
- embracing 6s

**Quality**: Ensure the quality of our products to ensure patient safety and achieve our mission of “Saving and Sustaining Lives”. This can be achieved through:

- +++following Good Manufacturing Practices (GMP) +++
- adhering to all quality procedures
- completing training on-time
- Doing it Right the First Time, and
- reporting any quality concerns immediately.

As part of the plant’s **Enterprise Management System (EMS**), all employees must embrace a culture of Continuous Improvement by:

- participating in improvement activities
- identifying and implementing continuous improvement ideas
- participating in Tier meetings
- recognizing your peers, and
- embracing 6s.

An additional general expectation for the person in this role is to ensure that the culture levels of Simplification-Speed-Collaboration-Courage are role-modeled and demonstrated through results.

**What You'll be doing**:
**a. Lead the management of activities of the Quality Systems team to ensure that the site Quality System is maintained in compliance to applicable Canadian, Global Quality and regulatory requirements. Major responsibilities include**:

- Implementation of key Quality System Elements (described under Summary of Responsibilities).
- Oversight of the Alliston Quality System considering Risk Management principles, in alignment to Baxter Quality global processes and regulatory expectations.
- Assisting the QMR by coordinating and monitoring activities related to the site Quality Plan, working in partnership with all site functions.
- Scheduling and coordinating Quality Management Reviews, including development of contents based on Management Review GQP and site SOP.
- Ensuring new/ revised SOPs, NCRs, Change Controls, APQRs, and other GMP processes/ procedures are developed, reviewed and approved with the required rigor, considering interfaces throughout elements (e.g., Documentation & Training; Change Controls) and in alignment to Baxter Global Processes.
- Ensure Change Control/Product Control Specifications related to Label changes are managed, controlled and implemented.
- Ensuring there are investigations commensurate to the nature (e.g., severity, issue, rate of occurrence) of the gap/ deviation.
- Leading the site NCR/ CAPA Review Board.
- Ensuring the nonconformance and CAPA processes, in conjunction with their triggers remain in control in terms of compliance to procedures, and that significant issues (from Exceptions, Out of Tolerance in addition to NCRs) are considered for deviation trending.
- Ensuring frequent communication and engagement with Batch Release, Manufacturing, QC Laboratories, Engineering and other Operational function representatives to ensure connection between day to day, Quality System element activities (e.g., NCRs, Change Controls) considering product supply needs.
- Responsible for coordinating and deploying training/coaching to site personnel on Trackwise (for NCRs, Complaint Handling System).
- Manages the Scheduling, coordinating, and leading of site Quality Key Process Indicators (KPIs) data compilation, analysis, identification and follow through of actions for various Quality forums or site meetings with Quality agenda topics (e.g., Quality dashboard, OBS, quarterly Quality Management Reviews).
- Review and provide QA approval of procedures, Out of Limit investigations, Trending Reports and other GMP documents corresponding to the Quality Control Laboratories.
- Driving the Annual Product Quality Review process, ensuring steps from coordination of data gathering through reaching product quality and related processes conclusions are implemented to ensure a timely submission of Annual Product Quality Review reports.
- Ensuring processes are implemented on site to consider evolving regulatory expectations. Liaise wit

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