Senior Director, Quality Assurance

AbCellera is breaking the barriers of conventional drug development to propel antibody-based medicines from target to clinic. We are a team of scientists, engineers, creatives, and business professionals who believe that advancing science enhances lives. We have developed technologies to unlock high-value drug targets, including antibody-drug conjugates and T-cell engagers for cancer, and complex transmembrane proteins for indications such as metabolic and endocrine conditions, pain, and autoimmunity.

We are looking for a motivated Quality leader to become the Senior Director, Quality Assurance. You will be responsible for building a team and designing quality systems to meet an audacious goal: to go from Discovery to fill-finish in a year. You will be given the freedom to move at lightning speed to create a legacy in our industry.

How you might spend your days

• Providing exceptional leadership to the organization, including hiring, mentoring and developing staff
• Building the QA organization (CMC/GxP) and establishing, directing, coordinating and managing the reporting Quality Assurance (QA) functions
• Developing and providing lifecycle management of the vendor/supplier selection, qualification and governance processes and internal/external audit programs
• Designing, implementing and reviewing the Quality Management System (QMS) including deviations, change controls, CAPA, Annual Product Quality Review (APQRs), audit and inspection management programs, complaint management, recalls, etc.
• Designing and implementing the document management system, quality risk management, knowledge management programs and systems
• Designing and implementing quality governance, quality escalation and quality management review processes
• Participating in the selection and governance/management of external vendors (e.g. CDMOs/CROs), leading quality due diligence activities and the negotiation, management and review of Technical Quality Agreements (QTAs), Knowledge Management/Data Integrity procedures/policies, etc.
• Designing and management of equipment, facility, utility and related computer system validation programs. Ensuring implementation of facility/equipment/process control/monitoring/alarm programs where applicable
• Collaborating with internal/external/partner cross-functional teams to ensure the timely and compliant progression of projects in accordance with approved project plans
• Authoring and reviewing CMC INDs, BLAs, and other relevant regulatory dossier sections and strategizing to support responses to regulatory questions during review period and product lifecycle
• Developing, implementing and monitoring phase-appropriate GxP and compliance systems, procedures and policies
• Leading the Quality Assurance department program progression from lead candidate selection through pre-clinical, IND and/or commercial readiness (BLA) activities
• Reviewing and approving match manufacturing and testing records and performing the QA release function
• Ensuring activities and deliverables are in compliance with Health Canada, FDA, EMA and local regulations and guidance, ICH guidelines, AbCellera policies, SOPs and industry best practice

We'd love to hear from you if

• You have a bachelor’s degree or equivalent and 15+ years experience within the biopharmaceutical or device industry
• You have 12+ years experience in a quality organization in an FDA CBER/CDER and EMA regulated industry and you have previous experience within the areas of manufacturing or quality assurance
• You have 6+ years of experience building, leading, developing, coaching and mentoring a cross-functional team
• You have experience implementing phase-appropriate quality systems supporting CMC through IND/BLA in compliance with applicable regulations, guidelines and industry best practices
• You have the ability to develop an overarching CMC/GMP QA strategy and inspire a team to deliver upon AbCellera’s vision and goals
• You have a strong quality mindset and ability to influence across the entire organization
• 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

What We Offer

AbCellera’s hiring range for this role is $190,000 - $235,000, annually, commensurate with your education and job-related knowledge, skills, and experience. We base our salary ranges on localized market data ensuring competitive compensation. In addition to base salary, we offer equity, annual bonus dependent on team and company performance, and 6% (non-match) RRSP contribution.

At AbCellera, we have a number of initiatives to support AbCellerites in maximizing their work-life synergy. You will have a $1,500 annual active lifestyle allowance, professional development opportunities, and comprehensive health benefits. Scientific and technical mentorship is a priority. Abundant team and social groups to build community and connections within AbCellera are a given.