Compliance & Supplier Quality Lead - Mississauga, Canada - Resilience

Resilience

Verified Company

Mississauga, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

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 suppliernotified deviations/OOS events are reported, investigated, and closed out per internal policies and procedures. Engage with crossfunctional SMEs to ensure ontime assessment, closure, and remediation of reported supplier events.
Metrics/data analysis monitor supplier nonconformance 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 problemsolving 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 crossfunctionally; Track and trend meaningful metrics for assigned activities
Demonstrated ability to successfully execute responsibilities in a fastpaced 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