Supplier Quality Manager
AbCellera is transforming antibody drug discovery to bring better medicines to patients more quickly. We are constructing a process development and manufacturing facility in Vancouver, Canada, where our Tech Ops team of scientists and engineers will oversee the manufacturing processes for antibody therapeutics.
The Manager, Supplier Quality will be responsible for the quality oversight of suppliers of the materials, equipment and services that will support development and manufacturing of monoclonal antibodies. The role will be involved during all steps of the Supplier lifecycle: Selection, Qualification, Management and Decommission.
The Manager, Supplier Quality will conduct Quality oversight of suppliers during all product’s development steps including cell line development, toxicology batch manufacturing, analytical method verification/qualification, clinical DS / DP batch manufacturing and testing.
AbCellera’s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.
We’re offering a generous compensation package including an equity stake in AbCellera’s success. Our future facility will be nestled in the heart of Vancouver, Canada - we’ll support you and your family in every way we can to relocate if you haven't had the joy of living in this beautiful area!
We’d love to hear from you if
- You are strongly self-motivated and are able to identify project needs and follow that up with building and implementing solutions
- You are passionate about working with dynamic new teams and capabilities that accomplish ambitious goals
- You are enthusiastic about applying your expertise in external quality assurance
- You are an outstanding communicator with external partners and a teammate
How you might spend your days
- Overseeing a portfolio of suppliers providing activities such as supply of raw material, reagent, media and equipment, and services supporting CMC-GMP such as maintenance, calibration, qualification, distribution and storage
- You will be accountable for Suppliers quality management activities including: Deviations, Change Management and Complaints
- Working with key stakeholder groups (e.g. Procurement, Operations, QC, Supply Chain, Process Development, Legal, Partners), for the Selection, Qualification and Management of Suppliers
- Negotiating and maintaining Quality Agreements between AbCellera and Suppliers
- Supporting CMC Regulatory submissions
- Defining, monitoring and reporting quality performance metrics
- Ensuring implementation at the Supplier of a compliant data management process and other AbCellera quality initiatives
- Performing quality risk assessments, developing mitigation plan and following-up on implementation of corrective actions
- Maintaining Supplier site readiness for Regulatory inspections & for AbCellera /partners/ 3rd parties audits
- Participating in on-site regulatory inspections and audits
- Supporting Health Authority inspections and audits outcomes and ensure implementation of associated action plans
- Maintaining current knowledge of applicable Quality & Regulatory requirements and evolving trends and supporting the Suppliers to meet these standards
Required qualifications and experience
- A Bachelor or Master’s degree in a relevant discipline and 8+ years of GxP industry experience within biotechnology, pharmaceuticals, or life sciences
- 5+ years of supplier/vendor quality management experience in a GxP regulated environment such as within biotechnology, pharmaceuticals, or life sciences
- Strong comprehension of current pharmaceutical regulations and guidances (FDA/Health Canada/EU/ICH) and regulatory expectations for assigned function
- Good ability to assess vendor quality core processes ensuring compliance with relevant guidelines and procedures
- A thorough understanding of drug substance development process and monoclonal antibody manufacturing processes and testing
- Strong experience with various software/databases such as, but not limited to, ERP, MES, eQMS and LIMS
- Excellent communication and presentation skills with an ability to adjust to both technical and non-technical audiences
- Results oriented, and able to effectively execute on projects with minimal supervision