GxP Supplier Quality Manager

Roche•Mississauga, ON

11d•Onsite

About The Position

At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. We serve our patients through external partnerships because access to quality products is every patient’s right. We leverage external partners in order to offer flexibility to our internal capacity at the right cost and quality. We enable our external partners to reliably deliver compliant, quality products to our supply chain customers, so that we can deliver to patients worldwide. We do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.

Requirements

B.S., M.Sc. or PhD in life sciences or equivalent.
7-10 years experience in GMP Manufacturing and Quality in the pharmaceutical or biotech industry.
Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals.
Ability to interpret quality standards as they relate to clinical GMP products.
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 for assigned roles and tasks, continuously willing to improve individual and team effectiveness.
Ability to communicate clearly and professionally in English, both in writing and verbally.

Nice To Haves

The ideal candidate has GMP QA experience in oversight of bulk API and Drug Product clinical supply operations including release.
Experience with Biologics is a plus.

Responsibilities

Provide quality and compliance oversight of CDMOs, CROs/PET centers, CLOs and in-licensing partners to ensure compliance with cGMP and quality agreement requirements.
Serve as the Quality Point of Contact for these GMP suppliers 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 a GMP supplier, especially CDMOs, including but not limited to: 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.
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.
Execute all required activities to assess and release clinical supply as part of the Make-Assess-Release process. This includes but is not limited to review and approval of specifications, master batch records, methods, method validation reports, and executed batch records.
Ensure resolution of complex investigations, change and risk assessments.
Perform disposition of outsourced investigational medicinal products in SAP, including API and Drug Product of Synthetic Molecules and Biologics.
Serve as Quality Point of Contact to the technical development team, and 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.