Director, QA Validation
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 450 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 Director, QA Validation will be responsible for establishing the overall Validation / Qualification Strategy, Standards, Plans and Procedures to support AbCellera’s CMC Process Development (PD) and GMP Clinical Manufacturing and Testing facilities. You will ensure compliance with applicable Health Authority regulations, guidelines and industry standards. You will be responsible for building and growing a team to help meet an audacious goal: to go from Discovery to Clinic in less than a year. You will be given the freedom to innovate and 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 haven't had the joy of living in this beautiful area!
This key role will be responsible for overseeing both internal and external facility, utility, equipment and process qualification/validation activities, including responsibility for ensuring implementation of appropriate CSV/CSA, Risk Management, and Data Integrity programs. The successful candidate will be a member of the Quality Assurance team working closely with both internal and external partners to ensure compliance, strategies, and schedules within these programs. They will also establish close working relationships across disciplines to advance multiple programs through clinical development and build out the technical capabilities within our innovative and growing company.
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 an outstanding communicator and teammate
- You demonstrate excellent problem-solving skills
How you might spend your days
- Managing Quality Assurance (QA) Validation programs for the facilities, utilities, manufacturing and QC lab equipment (incl. computerized systems) and processes.
- Establishing phase-appropriate Validation/Qualification Strategy, Standards, Plans and Procedures for AbCellera’s CMC Process Development (PD) and GMP Clinical Manufacturing and Testing facilities.
- Ensuring utilities and equipment have a successful and compliant initial validation and are subsequently maintained in a validated state.
- Supporting cross-functional teams during facility design and for the selection/procurement of new equipment/utility systems along with facilitating commissioning and qualification related activities.
- Participating in the facility and equipment design reviews.
- Performing Quality Validation Audits and providing Validation oversight of Equipment/Utility Suppliers and Service Providers (e.g. – CDMOs).
- Supporting internal and external audit programs.
- Reviewing and approving validation lifecycle documentation (e.g. URS, FRS, DQ, FAT, SAT, IQ, OQ, PQ, PV) protocols, reports.
- Performing Validation Risk assessments and Data Integrity evaluations in support of Validation Lifecycle Management (VLM) of equipment, facilities, utilities, processes.
- Ensuring Qualification/Validation activities are completed in accordance with project timelines.
- Overseeing validation execution work according to protocol instructions and procedures and ensure high quality and compliant validation packages and reports are approved and kept current.
- Coordinating and managing external suppliers to perform on-site validation activities (as required).
- Writing deviations that occur during validation/qualification and recommend corrective actions; participating in the resolution of gaps, investigations, and deficiencies.
- Reviewing and approving Discrepancies, Investigations, Change Controls, and CAPAs related to validated systems.
- Maintaining validation/qualification documentation and archiving to ensure efficient document retrieval.
- Providing QA Validation oversight for process validation, process performance qualification and continuous process verification.
- Supporting the establishment of a clear and inherent culture of Quality First and Right First Time (RFT) that ensures high transparency and collaboration between Quality, Operations and Engineering & Facilities.
- Establishing and maintaining compliance of the Validation program with applicable Health Authorities regulations (e.g. 21 CFR Part 11, 58, 210 and 211), guidelines and industry standards.
- In collaboration with Regulatory; authoring regulatory submissions related to the validation of facilities, utilities, equipment, and manufacturing processes.
- Serving as Qualification and Validation program Subject Matter Expert (SME) for regulatory interactions and during facility inspections/audits.
- Planning, organization, administration and general supervision of direct staff and contract personnel.
Required qualifications and experience
- Bachelor's or Master’s degree in a relevant scientific or engineering discipline and 12+ years of industry experience within pharmaceuticals, biotechnology or life sciences.
- 6+ years of Quality (QA) Validation leadership experience in a GxP regulated environment such as pharmaceuticals, biotechnology or equivalent.
- Recognized expert in the field of validation, and solid understanding of biologics Drug Substance (DS) and Drug Product (DP) process equipment, QC lab equipment, facility equipment such as autoclaves and WFI systems, and disposable manufacturing technologies.
- Extensive GMP Validation experience including Validation Master Plans, process, utility, and facility IQ/OQ/PQ, QC lab equipment validation, process validation (including PPQs and CPV), cleaning validation, hold time studies, and mixing studies.
- Excellent knowledge of global Health Authority (Health Canada, US FDA, EMA, HPRA, etc.) cGMP regulations (incl. US FDA 21 CFR Part 11), guidelines and relevant industry standards.
- Experience in IND/BLA regulatory section authoring and establishing audit/inspection readiness
- Significant experience with process risk assessment tools (e.g. FMEA), and facilitating risk assessments.
- Experience in managing and mentoring a quality team
- Demonstrated productive interactions with regulatory agencies and health authorities
- Strong interpersonal skills with the ability to work collaboratively as a member of cross-functional team
- Excellent documentation and organizational skills
- Superb verbal and written communication skills, including public presentation of complex data
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.
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