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 equipment and instruments who can lead quality oversight of validation activities and/or execute QA validation deliverables for these areas. As the QA Validation Manager, you will provide 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 facilities and utilities, 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, managing and developing the QA Validation team for QC instruments
- Establishing and maintaining quality validation processes to meet regulations
- Collaborating with instrument vendors for validation and troubleshooting
- Drafting essential QC validation documents and supporting CQV projects
- Reviewing and approving commissioning and qualification documents
- Assisting in the post-qualification procedures like calibration and maintenance
- Ensuring clarity and defensibility of approved validation documents
- Addressing validation-related investigations and implementing actions
- Representing QA/QC validation in interactions with health authorities
- Driving continuous improvement and goal-setting for new programs
- Collaborating across functions to resolve issues effectively and interfacing with external partners and regulators as needed
Qualifications
- BS, BA, or equivalent degree preferably in the Sciences or Engineering field, 8+ years Biotech / Pharmaceutical with Quality Compliance or QA Validation related work experience
- Familiarity with GCP, GMP, GDP, and GLP
- Proficiency in ISPE Baseline Guide Vol 5 and GAMP 5
- Strong grasp of relevant standards: USP, ANSI, ISO, ASTM, OHSA
- Knowledgeable about data governance and integrity regulations
- Experience in creating, reviewing, and approving validation documents
- Skilled in strategic thinking and risk-based decision-making
- Excellent oral and written communicator
- Expertise in CQV for various QC instruments and equipment
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.
About AbCellera
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.