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Roche
GxP Supplier ManagerRoche • Winnipeg, Canada
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GxP Supplier Manager

GxP Supplier Manager

Roche • Winnipeg, Canada
8 days ago
Job type
  • Full-time
Job description
Position Overview Provide quality and compliance oversight of CDMOs, CROs/PET centers, and in‑licensing partners to ensure compliance with cGMP and quality agreement requirements.

Responsibilities

Must 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 but not limited to 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 these GMP suppliers, including:

Develop, negotiate and maintain Quality Agreements and associated documents.

Monitor cGMP compliance and report quality performance; ensure key performance indicators such as on‑time closure of records are met.

Identify and mitigate quality risks; assess impact to Roche clinical product.

Support Roche audits, ensuring audit responsiveness and CAPA implementation; manage mitigation of findings prior to site implementation for Due Diligence audits.

Tech transfers, 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.

Qualifications

BS, MSc or PhD in life sciences or equivalent.

At least 8–10 years 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 and biologics including steriles; experience with siRNA is a plus.

Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals; 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 an innovation mindset.

Ability to work in a purpose‑driven organization, taking full ownership of assigned roles and tasks and continuously improving individual and team effectiveness.

Ability to communicate clearly and professionally in English, both in writing and verbally.

Travel Up to 10% domestic and/or international travel may be required.

Salaries and Benefits Expected salary range for the position based on the primary location of Mississauga is $136,936.00 to $179,728.50. Actual pay will be determined by experience, qualifications, and other job‑related factors. Relocation benefits are not available for this posting.

Equal Opportunity Employer Roche is an Equal Opportunity Employer.

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GxP Supplier Manager • Winnipeg, Canada

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