JOB OBJECTIVES<br>Ensure compliance of the supplier qualification program used to manufacture products at Juno and to support importation of finished dosage forms in Canada.<br>2. PRIMARY FUNCTIONS<br>Oversee the supplier qualification program applicable to (but not limited to) finished goods, excipients, API, packaging components, labels GxP service providers and production materials.<br>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.).<br>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.<br>Review external audit reports, CAPAs and supplier GMP evidence for DEL and Table A maintenance.<br>Own the supplier database, approved vendor list and audit/qualification calendar in electronic systems.<br>Propose actions for cost reductions and improved processes in the supplier qualification program.<br>Interact with internal and external sites to harmonize and optimize the audit program<br>Review and revise quality agreements with customers, wholesalers and suppliers.<br>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.<br>Maintain a robust virtual audit process.<br>Initiate and support change controls and ensure deviations or CAPA’s related to GxP suppliers are closed within established deadlines.<br>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.<br>Perform any other related duties deemed relevant to this position.<br>3. TRAINING, QUALIFICATIONS AND EXPERIENCE<br>Bachelor’s degree in engineering, chemistry, biology, microbiology or equivalent.<br>Pharmaceutical GMP auditor certification is an asset.<br>10 years experience in the pharmaceutical industry, preferably sterile injectables<br>Bilingualism (French and English), oral and written is an asset<br>*Location: Hybrid (Mississauga or Montreal) – Travel within Canada and internationally, up to 50% of the time.
