Manager, Quality Systems

1 week ago

Windsor, Ontario, Canada JAMIESON WELLNESS INC Full time
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Company Overview_
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Our Jamieson Diversity and Inclusion Statement_


At Jamieson Wellness, we cherish diversity, equality and inclusion and we know we must constantly listen, learn, and take action to ensure these principles remain embedded in our culture.

We encourage everyone to bring their whole selves to our table and create the differences that make us unique.

We are accountable to build an environment free of bias in regard to race, gender, sexual orientation, and all other types of discrimination.

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Overall Responsibilities_
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Specific Key Responsibilities & Duties_
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Quality Overview_

  • Ensures all computerized GMP Quality Systems are appropriately designed, installed, qualified, and maintained in compliance with industry standards and regulatory guidelines.
  • Maintains the validation master plan which governs all Jamieson Laboratory Sites.
  • Manages/Attends all Quality System & Validation meetings and prepares and edits meeting minutes, presentations, and tables.
  • Ensures department SOPs are maintained as per current regulatory guidelines and internal practices.
  • Complies with Good Manufacturing Practices in all GMP sensitive areas of Jamieson Laboratories facilities.
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Governance and Oversight_

  • Ensures all Quality Systems & Validation team members are provided with adequate ongoing training to effectively perform duties in compliance with GMP regulations.
  • Ensures validation studies provide scientific support that equipment, systems, and processes meet the defined validation requirements and are compliant with applicable regulations (and customer needs where stipulated).
  • Manages the maintenance of a detailed project database based on the respective site validation plans.
  • Coordinate the maintenance and circulation of all validation documents (hard and soft copies).
  • Determines potential gaps within core Quality Systems and Validation processes and identifies resources required to address the issues.
  • Tracks action items in risk assessments, determines the root cause, identifies obstacles, and seeks solutions.
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Leadership_

  • Manages/Supports/Develops all personnel related to Quality System & Validation activities.
  • Provides leadership across the organization for all Quality Systems & Validation related matters.
  • Oversee all validation activities relating to facility, equipment, manufacturing processes, and critical systems within Jamieson Laboratories facilities.
  • Owns/Manages summary documents and report project progress (problems and solutions) to all stakeholders including the Executive Leaders.
  • Acts as the primary Quality System & Validation management resource during client and regulatory audits.
  • Works in compliance with the company's Health & Safety Policies/SOPs, including but not limited to the Safety Responsibilities Procedure.
  • Implements and maintains department scorecards to monitor critical processes and department performance.
  • Escalates critical issues to executive management with proposed resolution actions in a timely manner.
  • Follows up with project contributors to ensure due dates are being actively managed to ensure project success.
  • Coordinates and participates in crossfunctional teams to develop project and partnership strategies with all stakeholders.
  • Coordinate the tracking of project changes and the preparation of updated schedules as agreed upon by the impacted departments.
  • Other duties and projects linked to Quality Systems & Validation as deemed necessary.
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Knowledge, Skills & Abilities Requirements_

  • University degree in Engineering or Science
  • 5+ years experience in a technical/manufacturing environment
  • 5+ years experience in a Quality role
  • 3+ years in a Leadership or Management role
  • Demonstrated success in project management.
  • Knowledge of project management techniques and tools.
  • Appreciation of how individual projects fit into broader corporate goals (e.g., financial goals, strategies, current quality systems, etc.).
  • An understanding of Jamieson's product line, the current project management process and relationships with existing project stakeholders is a strong asset.
  • A welldefined sense of diplomacy, including solid negotiation, conflict resolution, and people management skills.
  • Proven ability to influence crossfunctional teams without formal authority.
  • Highly effective project prioritization, multitasking, and time management skills to meet deadlines.
  • Excellent teamwork skills.
  • Outstanding written and verbal communication skills.
  • Energetic, selfmotivated, and results oriented.
  • Proven team player who is both flexible and adaptable.
  • Ability to chair effective meetings and to facilitate constructive discussions.
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Our Values_

ACCOUNTABILITY

  • We take personal ownership and pride in everything we do
  • We demonstrate a bias for action
  • We challenge the status quo constantly seeking to improve
  • We eliminate barriers and bias to empower others to achieve our goals
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