Quality Operations Manager
Baxter International
Alliston, ON
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SUMMARY OF RESPONSIBILITIES
Responsible for ensuring compliance of the following Quality Operations of the facility to the Quality Manual, Health Canada, Corporate and ISO requirements: Validation, Product Release, Label Control, In-Process and Final Inspections, Calibration, CAPA/Complaint root cause investigations.
Support a manufacturing 3-shift operation.
Partner with Quality and Production personnel to ensure robust complaint and CAPA investigations are performed and mitigating actions are identified and implemented.
Provide front line day to day management, coaching and technical support on product quality issues to ensure GMP, regulatory and procedural compliance and maintain high standards of quality to ensure root cause and preventative measures are identified and corrective and preventative actions are taken.
Provide support for the Quality technical review/approval of department related procedural changes, and validations/protocols.
Oversee the development, training, and coaching for the Alliston Lean Boot Camp and Greenbelt programs.
Support the Quality IT Systems for the department (i.e. SPC Infinity).
Responsible for recruiting, training, and coaching all direct reports.
ESSENTIAL DUTIES AND RESPONSIBILITIES

Manage the activities of the Quality Operations team to ensure that quality operations are performed in compliance with all the applicable local, Canadian, Corporate and regulatory requirements.
Provides front line day to day management, coaching and technical support on product quality issues to ensure GMP, regulatory and procedural compliance and maintain high standards of quality to ensure root cause and preventative measures are identified and corrective and preventative actions are taken.

Provides support for the Quality technical review/approval of department related procedural changes, and validations/protocols.

Remains current with respect to regulatory trends and divisional issues.

Partners with facilities, divisions, and regions to ensure knowledge sharing and successful implementation of Quality improvement initiatives.

Partners with the Quality Engineer team to manage the development, training, and coaching for the Alliston Lean Boot Camp and Greenbelt programs.

Support the Quality IT Systems for the department (i.e. SPC Infinity).

Manages the hiring, training, and development of Quality staff. Develops, coaches and mentors direct reports to achieve defined quality goals and results.

Ensures that effective programs are in place for all direct reports to facilitate development and to ensure compliance to set standards.

Develops direct reports to optimize resources and build team effectiveness. Apply decision-making skills in situations involving broad, pervasive and long-term impact.

Responsible for the management and preparation of the financial plan and maintenance of departmental budget.
Responsible for support in training/coaching of team members in Quality Systems (i.e. Trackwise 7, Trackwise 8, Complaint Handling System).
Responsible for facilitating and assisting in GMP, ISO and other internal/external plant audits and investigations as required.
JOB REQUIREMENTS

University Degree, Bachelor of Science (Chemistry, Microbiology, Pharmacy, Engineering)
Manufacturing & Quality background
Previous experience in a GMP environment
Previous quality opertions experience, including: validation, CAPA, Change Control, Documentation Systems, Training, Calibration, Label Control
People management experience including the ability to motivate and mentor
In-depth knowledge of GMP, ISO and Regulatory standards
Knowledge of Corporate Quality requirements
Practical experience using Lean tools (6S, Kaizen, Value Stream Mapping).
Minimum 7 years experience in quality assurance
3-5 years managerial experience
Strong understanding of Health Canada GMP and Medical Device Regulations.
Thorough knowledge of applicable procedures, specifications, regulations and standards.
Strong process and project management capabilities.
Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization.
Ability to build strong relationships with internal and external customers.
Strong ability to balance multiple priorities.
Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action.
Strong analytical and problem solving skills and critical thinking abilities.
Intermediate to Advanced proficiency in Word, Excel, Powerpoint.
Ability to support our transformation to a LEAN enterprise through the application of LEAN tools.
Proficiency in Trackwise System
Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the law - Poster Supplement

Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.