Supplier Qualification Specialist

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.