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 Director, Digital Quality Assurance (DQA) will be responsible for defining, maintaining and overseeing the strategy, plan and execution for Computer System Validation (CSV) within Operations and Quality (CMC/GMP) ensuring compliance to applicable global regulatory requirements (i.e. 21 CFR Part 11, Annex 11). This position will partner closely with various business functions across CMC/GMP to provide CSV expertise in order to meet the organization’s quality and operational objectives. 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 don’t yet have the joy of living in this beautiful area!
How you might spend your days:
- As the leader and go-to person for all aspects of validation/qualification for AbCellera’s Computer System Validation (CSV) and Computer Software Assurance (CSA) programs
- Developing the vision, strategy, roadmap and associated controls, including but not limited to policies, procedures and processes necessary to guide the implementation, maintenance and compliance of a CSV program that is appropriate for Abcellera’s business objectives
- Leading the development, implementation, modification and practice of Computer System Validation Standard Operating Procedures (SOP) and Information Technology (IT) GxP procedures based on current regulations and industry standards
- Interfacing with AbCellera’s CMC/GMP IT resources and other internal & external entities to align GMP shop-floor, QC laboratory, quality system and infrastructure technology capabilities/solutions with quality policies and objectives
- Partnering with stakeholders (e.g. System Owners, Process Owners, Data Owners and Technical Unit) to assess, select computerized systems which enable CMC/GMP business processes
- Ensuring digital technologies selected meet high-level business needs while encouraging innovation and ensuring compliance to applicable regulations and industry guidelines
- Managing and coordinating all aspects of CSV/CSA activities, including project planning, developing validation strategies, document development, document reviews and approvals
- Determining the appropriate level of qualification and validation necessary for computing systems to ensure holistic risk management balancing regulatory and compliance needs with business risks
- Reviewing vendor generated validation documentation to determine suitability and alignment with company CSV/CSA SOPs, 21 CFR Part 11 and GAMP 5 requirements
- Designing, implementing and overseeing risk-based computer systems validation activities (e.g., specifications, testing, qualification, and implementation). Guiding and reconciling any associated corrective and preventive actions needed to ensure compliance
- Ensuring procedures are in place to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans, etc.)
- Providing thought leadership and proactive innovation of best practices, process development/improvement and risk management for computer systems
- Maintaining expertise in current and emerging cGMP requirements, quality trends and IT technology trends that can impact CSV/CSA.
- Acting as the Subject Matter Expert for CSV during regulatory inspections and partner audits
- Conducting ongoing periodic assessments or audits of third party vendors
- Ensuring appropriate remediation plans are identified for gaps identified during the periodic reviews
- Collaborating within QA to monitor audit observations related to GxP computerized system and computer system validation to ensure gaps are identified and adequately addressed
- Driving the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, data integrity, electronic records/electronic signatures, maintenance and use of computerized systems, etc.
- Providing exceptional leadership to the organization, including hiring, mentoring and the development of staff
We’d like to hear from you if you have:
- Bachelors or Masters degree within a relevant discipline (e.g. IT, Computer Science) and 12+ years of relevant experience within the Pharmaceutical, Biotechnology or Life Sciences industry
- 8+ years of CSV leadership experience leading the implementation of cGMP regulations for computerized systems within a regulated GxP environment
- Demonstrated knowledge of data Integrity principles and requirement
- Direct experience with and comprehension of systems supporting pharmaceutical manufacturing and quality operations (e.g. ERP, MES, LIMS, LMS, QMS, DMS, etc.)
- Strong comprehension of the current pharmaceutical regulations and guidances (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 600, EU Annex 11, GAMP 5 and local regulatory expectations for assigned areas
- Extensive knowledge of the principles, theories and concepts of computerized system validation/compliance, data management and data integrity
- A thorough understanding of the drug development processes from discovery through CMC development, with an ability to understand business requirements and translate them into practical solutions
- A proven track record in delivering change and transformation projects and their associated benefits to an agreed time-line, budget and quality
- Previous experience in writing, reviewing, and executing computer validation. documentation including but not limited to Risk Evaluation, Risk Assessment, VMP, IQ, OQ, PQ, TM)
- Broad IT technical knowledge including the latest concepts and experience with SaaS and cloud-based systems in a GxP environment required
- Outstanding communication and presentation skills with an ability to adjust to both technical and non-technical audiences including business stakeholders and senior management
- Results oriented, and able to effectively execute on projects with minimal supervision
- CSV and CSV related certifications are highly desired
At AbCellera, we’re solving tough problems and creating innovative solutions from the ground up - custom immunizations, microfluidics, high-throughput imaging, genomics, computation, machine learning and laboratory automation - revolutionizing how our scientists can mine natural immune systems to discover new antibody therapies, and the scale at which they can do it. This is life-changing research and you could be a part of it.
You’ll join a diverse team of scientists, engineers, software developers, data scientists and business professionals - all working together to bring better therapies to patients.
We’re a growing company with a high-throughput tech stack and the drive to be the best in the industry. This isn’t just about having the best technology, it’s also about having efficient and seamless operations based on teamwork and cutting-edge tools. We know we need a world-class team of visionaries and innovators across the entire organization. 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, nurture, and organize our efforts along the way.