AbCellera is breaking the barriers of conventional antibody discovery to bring better medicines to patients, sooner. Our engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic with precision and speed.
AbCellera is in search of a QA Validation Manager for cGMP manufacturing equipment who can lead quality oversight of validation activities and/or execute QA validation deliverables for these areas.
The position provides guidance and hands-on support for multiple, complex validation projects, ensuring all qualification and validation activities adhere to regulatory requirements, industry standards, and the AbCellera Site Validation Master Plan and associated procedures.
We’d love to hear from you if
- You are a passionate leader who can motivate, inspire, and build highly effective teams while managing for high performance and the development of others.
- You have management experience overseeing validation activities for manufacturing equipment, work well within cross-functional teams, and have experience providing QA oversight and support for the planning of commissioning, qualification, and validation activities.
How you might spend your days
- Leading and nurturing the QA Validation team for facilities and equipment.
- Establishing and maintaining high-quality validation processes aligned with regulations.
- Collaborating with vendors for troubleshooting and data leverage in facilities and utilities validation.
- Playing a key role in creating vital validation documentation for CQV projects.
- Developing, reviewing and endorsing commissioning and qualification documents and ensuring inspection readiness.
- BS or equivalent degree, preferably in Sciences or Engineering.
- 8+ years experience in Biotech/Pharmaceutical industry, with Quality Compliance or QA Validation background.
- Proficiency in GCP, GMP, GDP, and GLP.
- Strong knowledge of ISPE Baseline Guide Vol 5, ISPE GAMP 5.
- Familiarity with standards: USP, ANSI, ISO, ASTM, OHSA.
- Expertise in data governance/integrity, including 21 CFR Part 11, Annex 11, FDA Draft Guidance.
- Experience in creating, reviewing, and approving validation documentation.
- Demonstrated critical thinking and risk-based decision-making.
- Excellent oral and written communication skills, including constructive challenges and issue resolution.
- Experience with standard equipment for biological products, including Single-Use bioreactors, chromatography columns, freezers, cryofreezers, isolators, and autoclaves.
What We Offer
AbCellera’s hiring range for this role is $92,000 - $115,000, annually, commensurate with your education and job-related knowledge, skills, and experience. We base our salary ranges on localized market data ensuring competitive compensation. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and 6% (non-match) RRSP contribution.
At AbCellera, we have a number of initiatives to support AbCellerites in maximizing their work-life synergy. You will have a $1,500 annual active lifestyle allowance, annual vacation and company-wide office closures (a real value to all!), opportunity for flexible work arrangements, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. Abundant team and social groups to build community and connections within AbCellera are a given.
At AbCellera, we find the next generation of therapeutic antibodies. To succeed, we have created innovative solutions at every step - custom antigen preparation and immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - leaving no stone unturned and revolutionizing how scientists can explore natural antibody diversity and the scale at which they can do it. You’ll join a diverse and multi-disciplinary team of biologists, biochemists, engineers, bioinformaticians, computer scientists and physicists - all working together to bring better therapies to patients. This is life-changing research and you could be a part of it.
We’re a growing company with state-of-the-art discovery tools and the drive to be the best in the industry. This isn’t just about having the best technology. We know we need a world-class team of innovators working together to solve the toughest problems. We look for people with drive and energy. Idealists. People we love and people we trust. This may be unconventional, but it is the key to our success. We’re looking for someone like you to support and organize our efforts along the way.