Director, QA Operations
AbCellera is breaking the barriers of conventional antibody drug discovery to bring better medicines to patients, sooner. AbCellera’s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.
The Director, Quality Operations will be responsible for providing direct quality oversight for the Drug Substance (DS), Drug Product (DP) and Finished Drug product (FDP) operations at AbCellera’s state-of-the-art Clinical Manufacturing facility. As the responsible QA Director overseeing all internal manufacturing operations, you will play an important role in ensuring that our products, processes and procedures meet the highest standards of quality and compliance.
We’re offering a generous compensation package including an equity stake in AbCellera 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!
We’d love to hear from you if
- You are strongly self-motivated and able to identify project needs and follow that up with building and implementing solutions
- You are passionate about working with dynamic new teams and building capabilities that accomplish important goals
- You are enthusiastic about applying your expertise in quality assurance
- You are an outstanding communicator and teammate
- You work well in cross-functional ways with non-quality members
How you might spend your days
- Providing leadership and direction for the Quality Operations team in charge of the quality oversight of Drug Substance (DS), Drug Product (DP) and Finished Drug Product (FDP) manufacturing operations.
- Managing the Quality processes, procedures, systems, standards, and tools to provide proper quality oversight of DS manufacturing operations, including the direct oversight of activities such as Contamination Control Strategy (CCS) development, product changeovers/line clearance procedures, media fill program execution, visual inspection of DP, etc.
- Overseeing the review of GMP documents and raw data, including Executed Batch Records for compliance with applicable procedures and standards (incl. Data Integrity) and to ensure proper testing and disposition of in-process and final product.
- Managing Quality events such as Deviations/Investigations (incl. Product Complaints), CAPAs, and Change controls related to the GMP manufacturing operations.
- Developing, monitoring and reporting department KPI/metrics for the purpose of driving Continuous Improvement across the site.
- Maintaining close collaboration with other Quality departments, such as Digital Quality, Quality Control, Quality Systems, Supplier Quality, QA Validation and QA for QC.
- Partnering closely with cross-functional stakeholders, such as Operations, MS&T, Product Development, Facilities and Supply Chain, to ensure compliance to quality standards across the site.
- Supporting the preparation, review and/or responses to Regulatory Health Authority submissions (CTA/IND, etc).
- Maintaining site inspection readiness and actively participate in Regulatory inspections / company audits and department related actions. Monitor and ensure timely implementation of associated action plans.
- Maintaining current knowledge of applicable Quality & Regulatory requirements and evolving trends and ensuring that the manufacturing site meets these standards.
- Sustaining a culture of Quality and Continuous Improvement throughout the site.
- Providing exceptional leadership to the organization, including hiring, coaching, mentoring, engagement and development of staff.
- Managing direct and indirect costs associated with Quality Operations, within the company targets and budgets.
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 Operations management leadership experience within a GxP regulated environment.
- 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
- Strong experience with various software/databases such as, but not limited to, ERP, MES, eQMS and LIMS
- A strong quality mindset and ability to influence across the entire organization
- Results oriented and able to effectively execute on projects with minimal supervision