Compliance & Supplier Quality Lead

2 weeks ago

Mississauga, Ontario, 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 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

  • Supplier Quality Team Lead

    2 weeks ago

    Mississauga, Ontario, Canada Boston Scientific Corporation Full time

    Supplier Quality Team Lead: Remote Eligible: Hybrid Onsite Location(s): Mississauga, ON, CAAdditional Locations: Canada-ONMississaugaDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...

  • Supplier Quality Technician

    2 weeks ago

    Mississauga, Ontario, Canada Romet Limited Full time

    JOB TITLE:Supplier Quality TechnicianLocation: Mississauga***Why you should come work with the Romet Team: We offer market competitive salaries:- Annual bonus plan:- 100% company paid benefits:- Group retirement plan:- Training opportunities:- Social events, a great team and moreROMET Limited was founded in 1972. Today, Romet is an international market...

  • Supplier Quality Manager

    2 weeks ago

    Mississauga, Ontario, Canada PACCAR Full time

    Job Description:This position will be based at the PACCAR St. Therese Plant in Montreal, Canada.About the Company: PACCAR is a renowned Fortune 500 company founded in 1905. The company is a global leader in the commercial vehicle industry, offering a wide range of services under well-known brands like Kenworth, Peterbilt, and DAF trucks. PACCAR specializes...

  • Supplier Quality Assurance Analyst

    2 weeks ago

    Mississauga, Ontario, Canada Romet Limited Canada Full time

    JOB TITLE:Supplier Quality Assurance AnalystLocation: Mississauga***Why you should come work with the Romet Team: We offer market competitive salaries:- Annual bonus plan:- 100% company paid benefits:- Group retirement plan:- Training opportunities:- Social events, a great team and more***ROMET Limited was founded in 1972. Today, Romet is an international...

  • Quality and Compliance Associate

    2 weeks ago

    Mississauga, Ontario, Canada Seaford Pharmaceuticals Inc. Full time

    Under the direction of the department manager, the Quality and Compliance Associate is responsible to carry out Quality Assurance functions at Seaford Pharmaceuticals to ensure compliance with all regulatory requirements applicable to Seaford's operations.The Quality and Compliance Associate will provide oversight and guidance in matters of Quality and...

  • Quality Assurance Compliance Associate

    2 weeks ago

    Mississauga, Ontario, Canada Randstad Full time

    Our client in the food industry in Mississauga, ON is looking for a Regulatory and Quality Assurance Specialist to join their growing team.The Regulatory and Quality Assurance Specialist will report directly to the Quality Assurance Manager. Your role will involve ensuring compliance with industry regulations and upholding high product quality standards....

  • QA Compliance Specialist

    2 weeks ago

    Mississauga, Ontario, Canada Bora Pharmaceutical Services Full time

    Location:***- Mississauga, ONDate Posted:***- 8/23/2023Job Number:***- JO Why join Bora? Competitive salary A modern and stateoftheart facility An onsite cafeteria with dedicated chefs Onsite gym, basketball, and tennis courtsClick here for a video tour of our Mississauga facility:TITLE: QA Compliance Specialist- DEPARTMENT:Quality Assurance- POSITION...

  • Quality Assurance Lead

    2 weeks ago

    Mississauga, Ontario, Canada The Central Group Full time

    Quality Assurance Lead (Mississauga, ON) Central is an industry leader in performance-driven marketing-at-retail solutions; specializing in both packaging and point-of-purchase (POP) displaywith clients across North America. Our dynamic company offers employees a collaborative, client-focused and business casual workplace with excellent benefits, and a...

  • Procurement Quality Assurance Representative-Lead Auditor

    2 weeks ago

    Mississauga, Ontario, Canada AtkinsRéalis Full time

    Job ResponsibilitiesThe Quality Assurance Specialist/Procurement Quality Assurance Representative "PQAR" reports to the Procurement/Project Quality Assurance Manager. He/She is responsible for:Planning, performing, and documenting surveillance activities on suppliers by verifying, witnessing/observing their fabrication, inspection, and testing, and reviewing...

  • Supplier QA Analyst

    2 weeks ago

    Mississauga, Ontario, Canada Romet Limited Full time

    JOB TITLE:Supplier Quality Assurance Analyst - ElectronicsLocation: Mississauga***Why you should come work with the Romet Team: We offer market competitive salaries:- Annual bonus plan:- 100% company paid benefits:- Group pension plan:- Training opportunities:- Social events, a great team and more***ROMET Limited was founded in 1972. Today, Romet is an...

  • Inventory and Supplier Relations Manager

    2 weeks ago

    Mississauga, Ontario, Canada MAD Elevator Inc Full time

    Inventory and Supplier Relations ManagerWe're looking for like-minded individuals to join our team.This is a Full-time, Salaried position.About The Inventory and Supplier Relations Manager:Are you an experienced professional ready to take on the role of Inventory and Supplier Relations Manager? Are you passionate about developing productive relationships...

  • Supplier Registration

    2 weeks ago

    Mississauga, Ontario, Canada TD Bank Full time

    TD DescriptionStay current and competitive. Carve out a career for yourself. Grow with us.Department OverviewTD spends nearly $10bn each year with Third Party (Suppliers). The Strategic Sourcing Group's ("SSG") role is to create sustainable competitive advantage for TD by leveraging this Third Party spend and the expertise of our suppliers, to meet our...

  • External Quality Manager

    2 weeks ago

    Mississauga, Ontario, Canada GSK Full time

    Site Name: Canada - Ontario - MississaugaPosted Date: Mar Are you excited by a job that maintains working relationships with the key contacts with CMOs and Suppliers? This will include Quality, Regulatory, Business Development, Production, Site Management and othersJob Purpose:This position is responsible for the Quality oversight of activities carried out...

  • Quality Compliance Specialist

    2 weeks ago

    Mississauga, Ontario, Canada American Tall Full time

    American Tall is a thriving e-commerce brand, dedicated to producing world-class quality clothing for tall men, and women, up to 7'1. Founded by a father and son duo in 2015, the business has grown to a level that seemed almost unimaginable just a few years ago and is now a leading brand in the tall community. The growth can be attributed to the excellent...

  • CRM & Marketing Administrator / E-commerce Website

    2 weeks ago

    Mississauga, Ontario, Canada Rev-Amp Electrical Equipment Ltd Full time

    Since 1996, Rev-Amp has led the way in refurbishing and wholesaling industrial electrical equipment. Our goal is to remain a leader and competitive. To that end, we are searching for a tech-savvy marketing person to fill the newly created position of CRM & E-Commerce Administrator.Job Purpose: This position is responsible for managing and optimizing the...

  • Data QA Lead

    2 weeks ago

    Mississauga, Ontario, Canada PACCAR Full time

    Position: Quality Liaison Company: PACCAR Inc PACCAR Inc is a leading company in the commercial vehicle industry, providing top-notch services and well-known brands like Kenworth, Peterbilt, and DAF trucks. They are seeking a Quality Liaison to work with suppliers on quality matters and ensure compliance with PACCAR standards. Lead suppliers through...

  • Entry Level Supplier Quality Engineer

    2 weeks ago

    Mississauga, Ontario, Canada Boston Scientific Gruppe Full time

    Press Tab to Move to Skip to Content Link Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access...

  • quality assurance supervisor/compliance

    2 weeks ago

    Mississauga, Ontario, Canada Norsk Hydro Full time

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Quality Manager Whether you're working to close the loop at one of our recycling facilities or ensuring efficient renewable energy processes to decarbonize aluminium production, your contributions make an impact in our shared purpose of propelling our industries and...

  • Supplier Diversity Manager

    2 weeks ago

    Mississauga, Ontario, Canada AstraZeneca Full time

    Position Summary: Position Summary : AstraZeneca is seeking a dynamic and experienced Supplier Diversity Manager to join our team. This role is pivotal in driving the implementation and tactical management of our supplier diversity program, aligning with our commitment to fostering an inclusive supply chain. Reporting directly to the Global Supplier...

  • Asset Data Management Quality Lead

    2 weeks ago

    Mississauga, Ontario, Canada GSK Full time

    Site Name: Canada - Ontario - MississaugaPosted Date: Apr Are you an enthusiast Data Management Expert looking into Project Management experience? If so, this Asset Data Management Quality Lead opportunity could be an exciting opportunity to consider.Job Purpose As Asset Lead Data Management Quality Lead you will be responsible for overseeing the endtoend...