Compliance & Supplier Quality Lead

6 months ago

Mississauga, Canada Resilience Full time

A career at Resilience is more than just a job - it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit

Position Summary & Responsibilities

This role assists in the quality oversight for suppliers/vendors used to manufacture, package, and test Resilience clinical and commercial products following Resilience policies, standards, procedures, and international cGMPs. The individual will assist with the review and will be responsible for the coordination and processing of supplier deviations and supplier change notifications as well as various other supplier quality activities related to raw materials, consumables, external labs, transportation suppliers, and more used for the manufacture, package, and testing of products manufactured by Resilience on behalf of its clients. The individual will also have responsibilities that include but are not limited to providing quality support to Resilience stakeholders and SMEs, and authoring/revising quality system documents as assigned. The Compliance and Supplier Quality is a key Supplier Quality role and reports to the Sr. Director of Compliance and Supplier Quality. The position can be physically located at any of the Resilience site locations listed and will ensure a close partnership with Site Quality teams in the management and oversight of GMP Suppliers and Service Providers.

Supplier Change Notifications - ensure internal documentation and impact assessment of supplier-communicated change following internal policies and procedures. Ensure associated quality agreements are current and not affected by the proposed change.
- Resilience Change Management activities - provide Supplier Quality impact assessment as required based on internally driven changes to GMP services, processes, materials, etc. Complete assigned change actions as required.
- Supplier Quality Events - ensure supplier-notified deviations/OOS events are reported, investigated, and closed out per internal policies and procedures. Engage with cross-functional SMEs to ensure on-time assessment, closure, and remediation of reported supplier events.
- Metrics/data analysis - monitor supplier non-conformance data to identify systemic issues and facilitate remediation activities
- Quality Risk Assessment - support material and supplier risk assessments as requested
- Material Specification Approvals - provide Supplier QA approval for material specifications in alignment with internal processes and procedures

Perform all other job-related duties as assigned by Sr. Director, Compliance and Supplier Quality

Minimum Qualifications
- Strong knowledge of cGMP in the Pharma/Biotech industry to include FDA, EU, and JP regulatory requirements as well as ICH/ISO guidelines
- Knowledge of aseptic and sterile product manufacturing processes and testing.
- Experience in Vendor Quality Oversight
- Thorough knowledge of and competence in core quality processes such as change control, deviations/OOS, CAPA, and complaints
- Excellent investigational and QA problem-solving skills - e.g. Able to interpret problems and effectively prepare surrounding communication in a product manner to management and the group with clarity, brevity, and accuracy; Ability to critically review investigations, interpret results, and generate compliant conclusions consistent with Quality risk management principles
- Demonstrate an analytical mindset - e.g. Able to assess vendors' quality core processes to ensure compliance with relevant guidelines and procedures; Able to recognize supplier quality risks and develop contingency plans; Able to assess, establish and implement new quality processes both internally and in partnership with assigned vendors. Able to author resulting procedures, documents, and tools as applicable; Able to recognize patterns in reported data and communicate strategic solutions to stakeholders cross-functionally; Track and trend meaningful metrics for assigned activities
- Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders
- Demonstrated skill in planning, organizing, and conflict management
- Ability to travel

Preferred Qualifications
- Bachelor’s degree or higher in Life Sciences, Chemistry, Engineering, or related field
- Minimum of 8 years of pharmaceutical industry experience, working in a Supplier Quality role, and/or Quality Compliance
- Experience in the biotechnology industry

BEHAVIOURAL:
Teamwork: Working effectively and productively with others

Leadership: Achieving extraordinary operational results through inspiring, encouraging and developing people

Goal Orientation: Energetically focusing efforts on me

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