Why Knight?
Are you looking for a dynamic workplace where rapid decision making, entrepreneurial spirit and community are embedded in the DNA? Headquartered in Montreal, Canada, Knight Therapeutics is a fast-growing specialty pharmaceutical company focused on acquiring or licensing innovative pharmaceutical products for the Canadian and select international markets.
If you think you have what it takes, contact us at careers@gud-knight.com.
Position Summary
The Manager, Quality Assurance, will assume responsibilities to ensure the compliance of Knight pharmaceutical products in Canada as well as to maintain Knight quality compliance with Good Manufacturing Practices (GMP) and the company Standard Operating Procedures (SOPs).
The ideal candidate is highly organised, details oriented, has good communication capabilities, demonstrate good problem solving skills and can adapt to changing priorities.
Reporting to: Quality Associate Director Canada and Latam
Specific Responsibilities
• Represent the company as the Quality Person in Charge (QPIC) for Health Canada.
• Elaborating internal processes for the development of the people from Quality Assurance department
• Generating of annual product quality review.
• Reviewing Quality Agreements.
• Managing of Deviations and CAPAs.
• Coordinating the timely collection of GMP evidence with corporate partners for product specific updates of Knight’s Canadian Drug Establishment Licence.
• Maintaining Knight’s Site licences and preparing related amendments and notification to Health Canada.
• Managing the lot release of pharmaceutical and natural health products to the Canadian market.
• Managing the changes made to marketed products.
• Handling marketed product complaints, in collaboration with corporate partners.
• Participating to on-site Health Canada GMP audits and, as required, conducting inspections of suppliers involved in the manufacturing and/or distribution of pharmaceutical and natural health products.
• Acting as the qualified person for quality compliance matters raised internally, by suppliers or corporate partners.
• Coordinating any required product recall procedure as per internal SOPs.
• Participating, to the preparation of CTD modules or responses related to the Chemistry and Manufacturing component of a regulatory dossier.
• Evaluate processes, results, operations, and trends in order to ensure compliance with local and international standards related to GMP, GLP, GDP. GSP, GPP
• Review quality KPIs and reports
• Support the implementation of the Quality Management System (software QMS)
Characteristics of a Good Candidate
2. Analytical and Organisational Skills
3. Negotiation skills / Teamwork
4. Autonomy / Problem Solving
5. Dealing with Ambiguity
Required
• Sc, M.Sc or PhD in Science
• Minimum of 6 years within the pharmaceutical industry, including Quality Assurance
• Strong scientific knowledge.
• Excellent communication skills; written and oral English; Spanish is desirable
• Strong knowledge of Microsoft Office Suite.
• Experience in People Management is desirable
Assets
• Knowledge of the Canadian regulations and good ability to interpret policies and guidelines
• Good knowledge of manufacturing process