Role:
You will love this role if you have a passion for science and medicine, you thrive in a fast-paced environment and enjoy contributing to drug development in an integrated communicative team environment.
The Quality System Specialist is responsible for overall development, implementation, and maintenance of the organization’s Quality Management System (QMS). In addition, this position will report to the President and CSO with oversight by the Vice-Presidents of Clinical, Manufacturing and Pre-Clinical Development. The Quality Manager will work in conjunction with Procurement, Manufacturing, and other departments that affect the quality of 35Pharma’s products.
This is a full-time position and is based in Montreal.
Duties and Responsibilities:
- Ensure 35Pharma’s organization Quality Management System conforms regulatory/legal requirements to customer, internal and contractors
- Ensure evaluation and reporting of vendor quality systems
- Manage the monitoring, measurement, and review of internal quality processes
- Ensure for managing a solid documentation system supporting data integrity
- Audit internal regulatory systems to ensure regulatory audit readiness
- You will develop risk-based strategies and be responsible for the GLP, GMP and GCP compliance oversight of internal and external operations
- Work closely with CMC to review and release batches and ensure documentation requirements are complete
- Ensure oversight and document control on non-conformities and change controls
- Make recommendations to lead management on performance of QMS (e.g., quality audit results, corrective actions), including the necessary improvements to achieve regulatory requirements
- Responsible for ensuring SOP implementation, training, and execution
- Responsible for employee training file maintain based on established guidelines by Department Directors
- Maintain standards, regulations, issues, and news with respect to product-service quality
- Occasional travel to vendor sites for audits, inspections or investigations may be required
Qualifications:
- A bachelor’s degree in engineering, science or quality is preferred, assorted to at least 5 years of relevant experience in Quality Assurance/Quality Control
- Hands on experience in managing a quality system and related expertise in GMP, GCP and GLP regulation
- Experience in regulatory submissions (IND, CTA, IMPD)
- Strong experience in non-conformity investigations
- Excellent communication skills and the ability to work well with people at all levels are essential
- Strong organizational, analytical, problem solving and management skills
- Efficient communicator both spoken and written
- Project management experience is an asset
- Experience with MS Office (especially Excel, Word) is required
Key words: Quality system, document control, audit
