Director – QA Operations
Updated on 11/30/2023
Accelerates antibody drug discovery with data science
AbCellera stands out as a leader in the biotech industry due to its unique approach to antibody drug discovery, combining expert teams, advanced technology, and data science to expedite the process from target to clinic across various therapeutic areas. The company's competitive edge lies in its ability to enable swift progress, cost reduction, and problem-solving in drug development for both innovative biotechs and leading pharmaceutical companies. Furthermore, AbCellera's commitment to technical innovation is evident in its recent presentation of new data on two T-Cell Engager Programs at SITC 2023, demonstrating its active role in advancing the field.
AI & Machine Learning
Data & Analytics
Growth & Insights
6 month growth↑ 16%
1 year growth↑ 38%
2 year growth↑ 100%
Vancouver, BC, Canada
Quality Assurance (QA)
QA & Testing
- Bachelor's or Master’s degree in a relevant scientific or engineering discipline
- 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
- 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.