The OpportunityProvide quality and compliance oversight of CDMOs, CROs/PET centers, and in‑licensing partners to ensure compliance with cGMP and quality agreement requirementsHave expertise and experience in the clinical product development lifecycle, production oversight, and release of clinical supplyExecute all required activities to assess and release clinical supply, including review and approval of specifications, master batch records, methods, method validation reports, and executed batch recordsLead resolution of complex investigations, changes and risk assessmentsPerform disposition of outsourced investigational medicinal products in SAP, including API and drug product of synthetic molecules and biologicsServe as the Quality Point of Contact for CDMOs, CROs and in‑licensing partners, and participate as a key member of cross‑functional management teams to enable site selection, qualification and implementation, management and decommissioningOversee and execute all required quality activities during the lifecycle of GMP suppliers, especially CDMOs, including: develop, negotiate and maintain quality agreements and associated documents; monitor cGMP complianceand report quality performance; identify and mitigate quality risks; support Roche audits, ensuring audit responsiveness and CAPA implementation; for due diligenceaudits, directly manage mitigation of findings prior to site implementation; tech transfers and process validation, and inspection readiness for commercial CDMOs as applicable; serve as quality point of contact to the technical development team, lead the quality subteam as required; execute the product specification file (PSF), intra‑company agreements,



approve the control system, review CMC sections of Health Authority submissions and related activitiesWho you areB.S., M.Sc. or PhD in life sciences or equivalentAt least 8-10 years of manufacturing and quality experience in the pharmaceutical or biotech industryGMP QA experience in bulk API and drug product clinical supply manufacturing operations, including release, preferably for synthetic molecules as well as biologics (incl. steriles); experience with siRNA is a plusSound knowledge of cGMP, ISO standards and international regulations; ability to interpret regulatory requirements and quality standards as they relate to clinical GMP product operationsExcellent quality decision‑making skills in complex environmentsProven ability to influence across cultures and functional reporting lines, and to drive continuous improvement initiativesAbility to operate in a self‑managed way of working, with a key focus on collaboration, agility and innovation mindsetAbility to work in a purpose‑driven organization, taking full ownership, continuously willing to improve individual and team effectivenessAbility to communicate clearly and professionally in English, both in writing and verballyTravelThis position may require up to 10% domestic and/or international travel.Salary and BenefitsThe expected salary range based on the primary location of Mississauga is $136,936.00 to $179,728.50. Actual pay will be determined based on experience, qualifications, and other job‑related factors as determined by the company.Relocation perks are not available for this posting.This posting is for an existing vacancy at Hoffmann‑La Roche Ltd.Roche is an Equal Opportunity Employer.#J-18808-Ljbffr

📌 Gxp Supplier Manager - C$136,936 - C$179,728.5 A Year (Winnipeg)
🏢 Hoffmann-La Roche
📍 Winnipeg