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Quality Systems Manager

Req #: 180006NI_en
Location: Alliston, ON CA
Job Category: Quality
Date Posted: 4/2/2018 12:28:58 PM
Baxter International

Description

Responsible for ensuring compliance of the following Quality Systems to the Quality Manual, Health Canada, Corporate and ISO requirements:  CAPA, Change Control, Data & Documentation Management, Label Copy Change(s), Complaint Evaluation, Management Controls, Training, APQR, Internal/External Assessments, and Supplier Quality. 

Schedules, coordinates, and leads the facility monthly quality scorecard review and quarterly management review meetings.

Responsible for recruiting, training, and coaching all direct reports.

 

 

Manage the activities of the Quality Systems team to ensure that quality systems are maintained in compliance all the applicable local, Canadian, Corporate and regulatory requirements.   

 

Oversees the Alliston Risk Management Process in compliance with Regulatory Requirements, Corporate Quality System Requirements and Local Implementing Procedures.

Supports the following activities:

ü  Risk Management Documentation Maintenance (including but not limited to Process Flows, PFMEAs, and Control Plans)

ü  Control Plan Lead for the Alliston Facility

ü  FDA 483 Reviews

As a member of the Alliston Management Team participate in the Strategic Planning process which includes the development and cascading of departmental goals and objectives linked to the Corporate and facility Strategic Plan.  Monitor and report on the effectiveness and value of these goals by participating in various VIP, Quality, Project and Quarterly Management reviews. Prepare department budget and execute to it. Manage, motivate and assess staff performance to ensure the achievement of individual and departmental goals thereby supporting the success of the plant and Corporate objectives.

 

Act as liaison for third-party customers.

Reviews Corporate Quality Procedures and policies and new/revised Health Canada guidance documents/regulations to ensure local procedures are maintained appropriately.

May perform Instructor Led CCM training for the Alliston Facility and acts as a facility system expert.

 

 

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.


Qualifications

Education Level

Required:

·          University Degree, Bachelor of Science

Preferred:

·          

Major Subjects / Specialties

Required:

·          Science (Chemistry, Microbiology, Pharmacy, Engineering)

Preferred:

·          

Type of Experience

Required:

·         Manufacturing & Quality background

·         Previous experience in a GMP environment

·         Knowledge of GMP, ISO and Regulatory standards

·         People management experience including the ability to motivate and mentor

Preferred:

·          Knowledge of Corporate Quality requirements

·         Practical experience using Lean tools (6S, Kaizen, Value Stream Mapping).

Years of Experience

Required:

·          Minimum 7 years experience in quality assurance

·         3-5 years managerial experience

Preferred:

·         10+ years experience in quality assurance

·         5+ years managerial experience

Additional Skills / Special Training / Technical Skills Required

Required:

·         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.

 

Preferred:

·         Ability to support our transformation to a LEAN enterprise through the application of LEAN tools.

·         Proficiency in Trackwise System

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