City of Winnipeg Health jobs

About us

Grifols is a pharmaceutical manufacturer licensed by Health Canada and certified by the European Union (EU) and the International Quality Plasma Program (IQPP). Grifols is a source member of the Plasma Protein Therapeutics Association (PPTA).

Grifols collects quality plasma from healthy donors. That plasma is used for further manufacturing into therapies to treat various health conditions.

Position Summary:

The Quality Regional Manager(Atlantic Canada) is responsible for overseeing all on-site quality systems and related processes to ensure that all quality standards of the company are being followed and implemented as written. The Quality Regional Manager is also responsible for overseeing the direct work of the local Quality Systems Managers and escalating any potential issues to the Quality Director where applicable.

Position Objective:

To ensure all on-site activities, processes, procedures, equipment, and quality systems are being executed in the respect of national and international standards and as expected.

Position Responsibilities:

1. Oversee all Quality Systems Managers and their associated job-related duties, functions, and overall center activities as related to the quality system.

2. Review and consult on day-to-day center activities of quality operations to ensure that all activities related to the quality system are compliant with SOPs and applicable federal and local regulations as well as Human Resources policies.

3. Review of documentation related to the local Quality Department, including but not limited to SOP/APP, reports, records, test results, and equipment logbooks.

4. Review and revise central documentation like SOPs/APPs, policies, or manuals as required. Identify potential SOPs revisions as needed to support continuous improvement.

5. Manage creation and coordination of change control procedures.

6. Oversee the scheduling of equipment maintenance, qualification, validation, and calibration as required.

7. Stay current with federal, provincial, local, and company-specific rules, regulations, and practices. Maintain a high level of working knowledge for national andinternational laws, regulations and standards.

8 Ensure plasma unit shipments are prepared and performed as per provincial and national standards and as per customers’ specifications.

9. Manage quality issues and CAPA’s within the company and at the management level as required.

10. Participate in regular internal audits of the centers as required.

11. Assist in execution of external audits performed by authorities and customers as required.

12. Provide regular reports to the Quality System Director on the status of the centers including the management of errors and non-conformities, training of staff, documentation and records, as well as general adherence to quality standards and procedures within the centers.

13. Train Quality Systems Associates and Quality Systems Managers in new CPR centers in all aspects of their function, including Good Manufacturing Practices (GMP) principles, adherence to procedures and protocols, and any software/hardware that is necessary to complete their duties.

NOTE: May be required to work weekends, evenings, and some holidays. This job may require 25% travel.

Required Skills, Qualifications, and Experience:

1. University degree in applied pharmaceutical sciences, general sciences or health care.

2. At least 4 years quality control and quality assurance experience in a GMP regulated environment

3. Certificate in Quality Assurance Management or equivalent recognized certification is an asset.

4. Proven ability to communicate and present effectively for training purposes

5. Proficient in usage and handling of computers and related peripherals

6. Managerial experience is an asset.

7. Working knowledge of Canadian Health laws, regulations, good manufacturing practice guidelines and international regulations (knowledge of European, ISO and/or FDA regulations is an asset)

8. Demonstrated analytical/problem solving skills and trending analysis education

**Location Requirements: The successful candidate must reside in, or be willing to relocate to, the Atlantic region of Canada. The role will be responsible for overseeing centres in Moncton, Fredericton, Saint John, Halifax, and Winnipeg. Preference will be given to candidates currently residing in one of these cities. **

Job Type: Full-time

Pay: $70,000.00-$80,000.00 per year

Benefits:

• Dental care
• Employee assistance program
• Life insurance
• Paid time off
• Vision care

Experience:

• Quality management: 3 years (preferred)

Willingness to travel:

• 25% (required)

Work Location: Hybrid remote in New Brunswick