1. JOB OBJECTIVES

Ensure compliance of the supplier qualification program used to manufacture products at Juno and to support importation of finished dosage forms in Canada.

2. PRIMARY FUNCTIONS

• Oversee the supplier qualification program applicable to (but not limited to) finished goods, excipients, API, packaging components, labels GxP service providers and production materials.
• Perform and follow up on audits of GxP service providers, in accordance with applicable pharmaceutical laws and regulations (Health Canada, FDA, EU, ICH, Ph. Eur., USP, etc.).
• Report audit findings to management and to suppliers, monitor supplier responses and review objective evidence of timely corrective action implementation for virtual or on-site audits.
• Review external audit reports, CAPAs and supplier GMP evidence for DEL and Table A maintenance.
• Own the supplier database, approved vendor list and audit/qualification calendar in electronic systems.
• Propose actions for cost reductions and improved processes in the supplier qualification program.
• Interact with internal and external sites to harmonize and optimize the audit program
• Review and revise quality agreements with customers, wholesalers and suppliers.
• Support customer audits and regulatory authority inspections (SME coaching, room set-up, review of issues, etc.) and ensure that the site's supplier qualification program is audit ready at all times.
• Maintain a robust virtual audit process.
• Initiate and support change controls and ensure deviations or CAPA's related to GxP suppliers are closed within established deadlines.
• Provide guidance to the site regarding the interpretation and implementation of current and new regulatory authority regulations to enhance the contract development / contract manufacturing operations (CDMO / CMO) domestically and for external auditing purposes.
• Perform any other related duties deemed relevant to this position.

3. TRAINING, QUALIFICATIONS AND EXPERIENCE

• Bachelor's degree in engineering, chemistry, biology, microbiology or equivalent.
• Pharmaceutical GMP auditor certification is an asset.
• 10 years' experience in the pharmaceutical industry, preferably sterile injectables
• Bilingualism (French and English), oral and written is an asset

Location: Hybrid (Mississauga or Montreal) - Travel within Canada and internationally, up to 50% of the time.