26 days old

Director, Digital Quality Systems (CSV)

AbCellera
Vancouver, British Columbia
  • Job Code
    220076
  • Job Type
    Employee
  • Job Status
    Full Time

AbCellera: Director, Digital Quality Systems (CSV)

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 Systems 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!

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 digital quality systems
  • You are an outstanding communicator and teammate 
  • You are results oriented, and able to effectively execute on projects with minimal supervision

How you might spend your days

  • Serve 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.
  • Develop 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.
  • Lead 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.
  • Interface 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.
  • Partner with stakeholders (e.g. System Owners, Process Owners, Data Owners and Technical Unit) to assess, select computerized systems which enable CMC/GMP business processes.  
  • Ensure digital technologies selected meet high-level business needs while encouraging innovation and ensuring compliance to applicable regulations and industry guidelines.
  • Manage and coordinate all aspects of CSV/CSA activities, including project planning, developing validation strategies, document development, document reviews and approvals.
  • Determine the appropriate level of qualification and validation necessary for computing systems to ensure holistic risk management balancing regulatory and compliance needs with business risks.
  • Review vendor generated validation documentation to determine suitability and alignment with company CSV/CSA SOPs, 21 CFR Part 11 and GAMP 5 requirements.
  • Design, implement and oversee risk-based computer systems validation activities (e.g., specifications, testing, qualification, and implementation). Guide and reconcile any associated corrective and preventive actions needed to ensure compliance.
  • Ensure 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.).
  • Provide thought leadership and proactive support regarding best practices, process development/improvement and risk management for computer systems.
  • Maintain expertise in current and emerging cGMP requirements, quality trends and IT technology trends that can impact CSV/CSA.
  • Act as the Subject Matter Expert for CSV during regulatory inspections and partner audits.
  • Conduct ongoing periodic assessments or audits of third party vendors.
  • Ensure appropriate remediation plans are identified for gaps identified during the periodic reviews.
  • Collaborate 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.
  • Provide exceptional leadership to the organization, including hiring, mentoring and the development of staff.

Requirements

Required qualifications and experience

  • Bachelors or Masters degree within a relevant discipline (e.g.  IT, Computer Science) and 12-15+ 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 requirements.
  • 6+ years experience building, leading and developing teams
  • 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.
  • CSV and CSV related certifications are highly desired

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. We’re looking for someone like you to support and organize our efforts along the way.

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Posted: 2022-11-01 Expires: 2022-12-01

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Director, Digital Quality Systems (CSV)

AbCellera
Vancouver, British Columbia

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