GxP Supplier Manager

The Opportunity   Provide quality and compliance oversight of CDMOs, CROs/PET centers, and in‑licensing partners to ensure compliance with cGMP and quality agreement requirements
Have expertise and experience in the clinical product development lifecycle, production oversight, and release of clinical supply
Execute 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 records
Lead resolution of complex investigations, changes and risk assessments
Perform disposition of outsourced investigational medicinal products in SAP, including API and drug product of synthetic molecules and biologics
Serve 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 decommissioning
Oversee 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 compliance and report quality performance; identify and mitigate quality risks; support Roche audits, ensuring audit responsiveness and CAPA implementation; for due diligence audits, 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 activities
Who you are   B.S., M.Sc. or PhD in life sciences or equivalent
At least 8-10 years of manufacturing and quality experience in the pharmaceutical or biotech industry
GMP 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 plus
Sound knowledge of cGMP, ISO standards and international regulations; ability to interpret regulatory requirements and quality standards as they relate to clinical GMP product operations
Excellent quality decision‑making skills in complex environments
Proven ability to influence across cultures and functional reporting lines, and to drive continuous improvement initiatives
Ability to operate in a self‑managed way of working, with a key focus on collaboration, agility and innovation mindset
Ability to work in a purpose‑driven organization, taking full ownership, continuously willing to improve individual and team effectiveness
Ability to communicate clearly and professionally in English, both in writing and verbally
Travel  This position may require up to 10% domestic and/or international travel.

Salary and Benefits  The expected salary range based on the primary location of Mississauga is $ to $. Actual pay will be determined based on experience, qualifications, and other job‑related factors as determined by the company.
Relocation benefits are not available for this posting.
This posting is for an existing vacancy at Hoffmann‑La Roche Ltd.
Roche is an Equal Opportunity Employer.

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