Each of us cares about someone who will need medicines. That’s why our vision is to repeatedly beat the odds to deliver breakthrough medicines to patients that need them. We pursue truth and scientific rigour and have the courage to work at the edge of the unknown. We're looking for an experienced QA Specialist to join our Supplier Quality Management team and help ensure the quality and compliance of the materials, equipment, and services behind our monoclonal antibody programs. In this role, you'll provide quality oversight of the suppliers that support our development and manufacturing activities. You'll be involved across the full supplier lifecycle, from selection and qualification through ongoing management and decommissioning, so that what comes into our process meets the standards our programs depend on. If you're a QA professional who enjoys building strong supplier relationships and takes pride in making quality part of every link in the supply chain, we'd love to hear from you. How you might spend your days * Selecting, qualifying, and managing a portfolio of suppliers that provide raw materials, components, reagents, and media, as well as services such as maintenance, calibration, and qualification * Partnering with Procurement, Operations, QC, Supply Chain, and Process Development on supplier selection, qualification, and ongoing management * Negotiating and maintaining Quality Agreements between our company and its suppliers * Managing supplier quality events, including deviations, change management, and complaints * Performing quality risk assessments, defining mitigation plans, and following through on their implementation * Monitoring and reporting quality performance metrics, and implementing continuous improvement initiatives * Keeping suppliers ready for regulatory inspections and for internal, partner, and third-party audits * Participating in Health Authority and partner inspections at our sites and ensuring associated action plans are implemented * Staying current on applicable quality and regulatory requirements and evolving industry trends We’d love to hear from you if * You have a Bachelor's degree in a relevant scientific discipline with 5+ years of progressive QA experience (or a Master's with 3+ years) in a regulated biopharmaceutical, medical device, or life sciences environment * You have expertise in supplier quality management, including supplier qualification, oversight, and performance monitoring * You have a deep understanding of global cGMPs and regulatory requirements (FDA, Health Canada, EMA, MHRA, PIC/S, ICH) covering biologics, medical devices, combination products, and clinical trials * You have proven experience managing supplier records and data, quality events, and audit reports in electronic Quality Management Systems and Enterprise Resource Planning system (e.g., Veeva, SAP) * You bring exceptional attention to detail and a firm commitment to data integrity * You communicate well and collaborate effectively across multidisciplinary teams What we offer AbCellera’s hiring range for this role is CAD $84,000 - $105,000 annually, commensurate with your education and job-related knowledge, skills, and experience. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and a 6% (non-match) RRSP contribution. You will have a CAD $1,500 annual Active Lifestyle Allowance, annual vacation, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. And you’ll find a strong sense of community and connections across AbCellera through our work, clubs, and socials. About AbCellera Creating medicines is the most important work we can do. We are a clinical-stage biotechnology company focused on discovering and developing antibody-based medicines in the areas of endocrinology, women’s health, immunology, and oncology. We have built a platform for advancing antibody drug programs from target to clinic, and we are using it to build our internal pipeline. Today, our pipeline includes two drug candidates in clinical development, two preclinical development candidates (DCs) in Investigational New Drug (IND)-enabling activities, and more than 20 active discovery programs across multiple modalities and indications. We believe that when tenacious people share a vision and work together, they can truly have a positive impact. That’s why we hire for character and intelligence, not just for CVs or experience. We look for people with drive and energy. People we trust. People who need to know their days are being well spent. That their work really matters. In the end, our success will be measured by the impact of our medicines. To apply Please submit your application through our website and refer to Job ID 23411 in your cover letter. We receive a large volume of applications and are only able to contact those who are selected for an interview. All communication from our Talent Discovery team will come from an @abcellera.com email address.

QA Specialist - Supplier Quality

Similar jobs

Explore related jobs

Similar jobs