Job Summary
The Quality Assurance Lead reports directly to the Director of Quality Assurance and Regulatory Affairs and supports the day-to-day quality activities of the organization. The QA Lead works closely with the Operations team and pharmaceutical clients to help ensure that storage, handling, and distribution activities are performed in accordance with applicable GMP/GDP requirements, company procedures, and client-specific quality requirements.
The QA Lead serves as a key point of contact for clients on routine quality matters and supports the investigation and resolution of quality events, including deviations, temperature excursions, complaints, CAPAs, and other quality-related issues. The role also supports audits, inspections, documentation, training, and the ongoing maintenance of the Quality Management System.
The QA Lead is responsible for identifying and communicating quality or compliance concerns and escalating significant or complex issues to the Director of Quality Assurance and Regulatory Affairs. The position works collaboratively with Operations and other internal teams to support a strong quality culture and ensure that client and regulatory requirements are consistently met.
This is a hands-on, client-facing role that requires regular in-person attendance to support operational needs, client requests, and effective communication with internal teams.
Essential Functions and Accountabilities
- Provide QA oversight for pharmaceutical warehousing, storage, handling, and distribution activities.
- Ensure operations comply with applicable GMP/GDP requirements, regulatory expectations, SOPs, and client Quality Agreements.
- Identify potential quality and compliance risks and ensure appropriate escalation and mitigation.
- Ensure client commitments and quality requirements are appropriately communicated to internal teams.
- Support the oversight of the Quality Management System and report any issues regarding the compliance status and performance of the company.
- Responsible for management of client and regulatory inspections and compliance activities by performing the following duties.
- Represents the company during government inspections; Manages regulatory inspections and external audits via preparation, hosting and implementing corrective actions as appropriate. Reporting of results to management (as required).
- Provide Inspection response
- Lead the implementation and monitor corrective and preventative actions
- Oversee the internal audit program to monitor compliance with corporate and government requirements
- Manage the training process and curriculum
- Support RA department in revision, renewal and upkeeping of Probus and Client’s licenses (DEL, MDEL, Site) that Probus is responsible for.
- Support RA department in New Product GMP compliance documentation review
- This position will work regular business hours, with occasional after-hours meetings to accommodate the needs of clients. Flexibility in scheduling is essential to ensure timely support and collaboration with clients across different time zones.
- Perform other duties as assigned by QA/RA Management team.
Qualifications
Education:
- Bachelor of Science degree in Biology or Chemistry
Experience:
- 5 or more years of experience in Logistics/Warehouse, Supply Chain, Manufacturing/Distribution in a GMP environment
- Excellent verbal and written expertise and strong interpersonal and collaborative abilities to engage with individuals at all levels, across the organization both internally and externally
- Strong understanding of GMP, Food and Drug Act, Medical Device Regulations, Natural Health Products regulation,
- Project Management, Technical aptitude, and the ability to see the bigger picture
- Understanding of Quality systems in a Good Manufacturing Practices (GMP) environment
- Understanding of managing financial budgets, and productivity metrics
- Strong problem-solving and decision-making skills in a team environment
- Ability to exercise initiative, sound judgement and decision making within the scope of authority
- Fosters an inclusive and respectful work environment for all.
Work Environment:
- Standard Office Environment
- Consistent physical activity efforts necessary to perform the job – walking, standing, sitting, lifting up to 10 kg (non repetitive)
Job Type: Full-Time, Permanent
Compensation: CA$80,000 - CA$90,000 annually
Benefits:
- Casual dress
- Company Events
- Dental care
- Extended Health Care
- On-site parking
** This role is a new opening role and is expected to report to the office, in person - not a remote or a hybrid position.
** We do not use (after LinkedIn Posting) artificial intelligence during the hiring process.
