Reporting to the Chief Operating Officer, the successful candidate will be responsible to oversee the development and implementation of our laboratory QMS and LIMS and to ensure that all operational activities including cGMP are compliant with Health Canada, FDA, and international regulations.
The successful candidate must have proven expertise in a GMP manufacturing context across benchtop, pilot, and commercial pharmaceutical manufacturing scales. They will work closely and collaboratively with the Director of Lab operations during the facility construction and commissioning.
Candidate must be willing to re-locate to Calgary, Alberta, Canada.
Areas of Responsibility
- Lead the development and implementation of a robust cGMP compliant quality management system (QMS) and laboratory information management system (LIMS).
- Develop, review and approve Standard Operating Procedures that are compliant with the Controlled Drugs and Substances Act, Food and Drugs Act, and the associated regulations and guidelines.
- Provide leadership and mentorship to the QA Department.
- Schedule and lead regular meetings with operations staff and provide weekly reports to the facility director.
- Set a minimum expectation for training and performance for operations staff and ensure that all activities are conducted in a compliant manner.
- Liaise with Health Canada and other Regulatory Agencies as required.
- Lead compliance audits, respond to audit reports, and submit mandatory reports as required.
- Review and approve compliance documentation including but not limited to validation reports, batch records, packaging records, materials specification, product specifications.
- Conduct inspections of distributors and wholesalers as necessary for GMP compliance.
- Implement recall procedures if necessary.
- Oversee the maintenance and renewals of Drug Establishment License(s).
- Participate in personal development and training sessions.
- Work in a safe manner that does not endanger yourself or co-workers.
- Strive to consistently uphold Psygen’s core values and mandate.
Qualifications and Experience
- Minimum B.Sc. in Chemistry, Microbiology, Biology, or related field. M.Sc. preferred.
- 10+ years of experience in the pharmaceutical manufacturing industry, specifically including QA, Quality Control and/or Drug Regulatory Affairs.
- 5+ years of experience in a management position.
- Excellent communication skills in English. Written, listening and verbal.
- High degree of computer literacy.
- Strong understanding of cGMP Guidelines, the Controlled Drugs and Substances Act, the Food and Drugs Act, and the associated regulations and guidelines.
- Familiarity with analytical methods and instrumentation.
- Proficiency of generating reports in a timely manner.
Psygen provides competitive compensation with solid opportunities for personal growth.
Only candidates selected for an interview will be contacted.
Psygen is an equal opportunity employer.
How to apply:
Please email Cover Letter and CV to email@example.com
|Location||Calgary, Alberta, Canada|
|Role||Director of Quality and Compliance|