AbCellera is an energetic, and rapidly growing tech company with an amazing team that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. Working at the interface of computation, engineering, and biology, AbCellera is rebuilding the front-end process of how drugs are discovered with a discovery platform that integrates modern technologies from engineering, microfluidics, single-cell analysis, high-throughput genomics, machine learning, and hyper-scale data science. With over 400 AbCellerites and growing, we’re expanding our capabilities to include CMC development and GMP manufacturing of antibodies to bring therapies from idea to patients, faster.
The Senior Director, Quality Assurance (CMC/GMP) will be responsible for building a team and designing quality systems to meet an audacious goal: to go from Discovery to fill-finish in a year. You will be given the freedom to move at lightning speed to create a legacy in our industry.
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 don’t yet have 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 building dynamic new teams and capabilities that accomplish important goals
- You have a bias towards innovation over industry standards
- You are enthusiastic about applying your expertise in quality assurance
- You are an outstanding communicator and teammate
How you might spend your days
- Providing exceptional leadership to the organization, including hiring, mentoring and developing staff
- Building the QA organization (CMC/GxP) and ensuring that all team members have the appropriate level of education, experience and training to support their assigned job functions
- Establishing, directing, coordinating and managing the reporting Quality Assurance (QA) functions (QMS/DMS QA, Supplier QA, QA Validation, Manufacturing QA, QA Release, Training, etc.)
- Developing, administering and maintaining Quality Assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
- Developing and providing lifecycle management for the design, qualification, operation and ongoing review of CMC/GMP facilities, including associated digital Quality systems (e.g. MES, QMS, VLMS, etc.)
- Developing and providing lifecycle management of the Vendor/Supplier selection, qualification and governance processes and internal/external audit programs
- Designing, implementing and reviewing the Quality Management System (QMS) including Deviations, Change Controls, CAPA, Annual Product Quality Review (APQRs), Audit and Inspection Management Programs, Complaint Management, Recalls, etc.
- Designing and implementing the Document Management System (DMS), Quality Risk Management (QRM), Knowledge Management programs and systems
- Designing and implementing Quality Governance, Quality Escalation and Quality Management Review processes
- Drafting and maintaining Quality Manual(s), Quality Plan(s), Drug Master File(s) (DMFs), Site Master File (SMFs)
- Participating in the selection and governance/management of external vendors (e.g. CDMOs/CROs), leading Quality due diligence activities and the negotiation, management and review of Technical Quality Agreements (QTAs), Knowledge Management/Data Integrity procedures/policies, etc.
- Designing and management of equipment, facility, utility and related computer system validation programs. Ensuring implementation of facility/equipment/process control/monitoring/alarm programs where applicable
- Collaborating with internal/external/partner cross-functional teams to ensure the timely and compliant progression of projects in accordance with approved project plans
- Authoring and reviewing CMC INDs, BLAs, and other relevant regulatory dossier sections and strategizing to support responses to regulatory questions during review period and product lifecycle
- Developing, implementing and monitoring phase-appropriate GxP and Compliance systems, procedures and policies; Leading the Quality Assurance department program progression from lead candidate selection through pre-clinical, IND and/or commercial readiness (BLA) activities
- Reviewing and approving Batch Manufacturing and Testing records and performing the QA release function
- Establishing and monitoring compliance with Good Documentation/Records, Data Integrity, and document retention requirements
- Ensuring activities and deliverables are in compliance with Health Canada, FDA, EMA and local regulations and guidance, ICH guidelines, AbCellera policies, SOPs and industry best practices
- Developing, implementing and monitoring the QA Opex/Capex budgets
- Identifying, analyzing and reporting Quality Assurance department metrics
Required skills and experience
- A Bachelor’s degree or equivalent work experience in QA Manufacturing Operations or related discipline
- 15+ years experience within the Biopharmaceutical / device industry.
- Previous experience within the areas of Manufacturing and/or Quality Assurance is considered to be an asset
- 12+ years experience in a Quality Organization in an FDA CBER/CDER and EMA regulated industry
- 6+ years experience building, leading, developing, coaching and mentoring a cross-functional team
- Excellent working knowledge of applicable industry regulations (FDA, EMA), guidance documents (e.g. ICH) and industry best-practices (e.g. PDA technical Reports)
- Experience implementing phase-appropriate quality systems supporting CMC through IND/BLA in compliance with applicable regulations, guidelines and industry best practices
- Experience and passion to build, lead and mentor a cross-functional team with the opportunity to leave a lasting legacy on the team, organization and the country
- The ability to develop an overarching CMC/GMP QA strategy and inspire a team to deliver upon AbCellera’s vision and goals
- Demonstrated a strong Quality mindset and ability to influence across the entire organization.
- Experience in leading, developing, coaching and mentoring a cross-functional team
- Experience in communicating and/or interacting with Regulatory Health Authorities in direct support of IND/BLA submissions and associated facility inspection activities
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.