Quality Assurance Manager

4 weeks ago

Toronto, Canada Positive Fulfillment Services Ltd. Full time

The Quality Assurance Manager will lead the day-to-day operations of the Quality team, overseeing adherence to Standard Operating Procedures (SOP), Good Manufacturing Practices (GMP), and driving continuous improvement initiatives within the organization. This role involves managing the quality aspects of products across pharmaceuticals, medical devices, and food sectors, ensuring compliance with relevant regulations and licenses. Additionally, the QA Manager will embody Positive's values in interactions with internal and external stakeholders, fostering a culture of quality and excellence.

**Responsibilities**:

- Develop and maintain the Quality Management System at Positive. Manage the Quality team to ensure that the facilities are operating up to or above GMP and all Health Canada and Client QA requirements.
- Prepare and document Standard Operating Procedures to manage operations effectively.
- Communicate and maintain relationships with all departments to ensure QA standards are adhered to throughout the organization.
- Facilitate the resolution of issues related to quality policies, procedures, regulations, and compliance, and sets action priorities.
- Provide expert guidance and support to staff in GMP areas.
- Overseeing the release of client products.
- Work with the HR department to develop training programs for staff and QA Team members.
- Manage, conduct, and monitor internal audits for continuous improvements.
- Liaise with Positive’s customers’ QA departments on all QA issues.
- Oversee audits conducted by customers, Health Canada and other governing bodies.
- Oversee the management of the Complaint program to ensure all critical trends are addressed appropriately and investigations are handled.
- Accountable for a safe working environment through the development of strategies focused on accident reduction.
- Lead the Health and Safety Committees in all facilities.
- Act as a primary point of contact for health and safety issues, product recalls, Health Canada, alarm monitoring call list, adverse events and facility security.
- Keep abreast of latest legislations and policy as it pertains to safety and quality.
- Oversight of regulatory licenses.
- Develop operating policies and procedures as necessary.

**Qualifications**:

- 5-10 years Quality Assurance management experience
- Multi-year experience (minimum 5-8 years) at the supervisory/management level
- Experience in dealing directly with Regulatory agencies/officials.
- Experience in collaborating with external Quality Assurance departments.
- Experience with ISO 13485 is considered an additional asset.
- Experience in managing regulatory licenses.
- Capable of leading by influence in matrix environment
- Excellent written and verbal skills
- Coaching site/operational unit quality team on compliance requirements

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