Gxp Supplier Quality Manager

The Position

Title: GXP Supplier Quality Manager

Division: PTQ (Pharma Global Technical Operations Quality)

Location: Mississauga, ON

Type: Regular Full-Time

Location: This position is office-based with a flexible hybrid option

Mission of external 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 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 do this through cross-functional collaborations ensuring quality process excellence and continuous improvement

Main Purpose of the Position

• Serve as the Quality Point of Contact (PoC) for designated suppliers and participate as a key member of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning
• Provide quality and compliance oversight for external GxP suppliers including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and quality agreement requirements

About the Job:

Technical Job Responsibilities

• Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements
• Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate
• As applicable, manage all required activities to support Make Assess Release (MAR) of commercial medicinal products including approval of master process documentation, resolution of investigations, assessment of changes, and monitor and report GxP Supplier quality performance
• As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs
• As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of continuous inspection readiness
• As applicable, support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements
• As applicable, manage or lead technical transfers for manufacturing, testing, packaging, and product launches
• As applicable, release, reject or quarantine commercial medicinal products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within the area of responsibility per applicable Swissmedic and Roche requirements on behalf of the Responsible Person (RP)
• Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Roche and Health Authority audits, complex investigations, market complaints, and regulatory submissions

Functional Job Responsibilities

• Troubleshoot and drive the resolution of quality issues, fostering effective interdepartmental and cross-functional partnerships
• Sign documents as authorized and described by Roche policies, procedures and job descriptions
• Maintain and communicate work priorities to meet goals and timelines
• Deliver business outcomes in support of departmental objectives
• Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance
• Timely complete all job-related training requirements prior to performing GMP-job functions and strive to continuously improve on knowledge and skills in quality, compliance and technology
• Identify, support and/or lead continuous improvement initiatives that may benefit External Quality and other organizations
• As applicable, deputize for the GxP Supplier Management Chapter Lead or a peer and assist with their duties if and when required
• Be accountable for behaviors described in Roche’s Code of Conduct
• Perform other quality related activities and projects in order to ensure quality and compliance and enable continuous improvement
• Communicate new and updated regulatory requirements and applicable Roche expectations to GxP suppliers as applicable, and evaluate systems in place
• Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations are aligned with Roche objectives
• May mentor and/or coach colleagues within and outside the organization

Who You Are:

• This position may require up to 10% domestic and/or international travel
• 8-10 years of experience in the pharmaceutical or related industry. Experience with quality management of GxP service providers is a plus
• Proven ability to influence across cultures and functional reporting lines, and to drive continuous improvement initiatives
• Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to GxP suppliers
• Fluency in oral and written English is a must. Additional language skills are a plus
• Demonstrate agile mindset and behavior
• B.A. or B.S. degree in life sciences or equivalent
• Highly competent in MS office or Google Suite applications including Excel, Powerpoint, Word, and MS Project, etc
• Ability to communicate clearly and professionally both in writing and verbally

This position is not eligible for relocation.

Employee may be located in Oceanside, South San Francisco or Mississauga.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.