AbCellera Biologics Hiring for Senior Director, Quality Assurance (CMC/GMP) at Vancouver, BC Full Time

MAY 16, 2022

Job ID: 220048

AbCellera is a technology company that searches, decodes, and analyzes natural immune systems to find antibodies that its partners can develop into drugs to prevent and treat disease. AbCellera’s full-stack, AI-powered drug discovery platform integrates modern technologies from engineering, microfluidics, single-cell analysis, high-throughput genomics, machine learning, and hyper-scale data science. AbCellera partners with drug developers of all sizes, from large pharmaceutical to small biotechnology companies, empowering them to move quickly, reduce costs, and tackle the toughest problems in drug development.

The Senior Director, Quality Assurance 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.

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 haven’t had the joy of living in this beautiful area!

How you might spend your days:
As a leader in the establishment of the GMP Manufacturing facility and operation, you will be:

Providing exceptional leadership to the organization, including hiring, mentoring and developing staff.

Building the QA organization (CMC/GxP) and ensuring that all team members have the appropriate level of education, experience and training to support their assigned job functions.

Establishing, directing, coordinating and managing the reporting Quality Assurance (QA) functions (QMS/DMS QA, Supplier QA, QA Validation, Manufacturing QA, QA Release, Training, etc.)

Develop, administer and maintain Quality Assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements.

Developing and providing lifecycle management for the design, qualification, operation and ongoing review of CMC/GMP facilities, including associated digital Quality systems (e.g. MES, QMS, VLMS, etc.).

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 (DMS), Quality Risk Management (QRM), Knowledge Management programs and systems.

Designing and implementing Quality Governance, Quality Escalation and Quality Management Review processes.

Drafting and maintaining Quality Manual(s), Quality Plan(s), Drug Master File(s) (DMFs), Site Master File (SMFs).

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 Batch Manufacturing and Testing records and performing the QA release function.

Establishing and monitoring compliance with Good Documentation/Records, Data Integrity, and document retention requirements.

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 practices.

Developing, implementing and monitoring the QA Opex/Capex budgets.

Identifying, analyzing and reporting Quality Assurance department metrics.

We’d like to hear from you if you have:
A Bachelor’s degree or equivalent work experience in QA Manufacturing Operations or related discipline.

15+ years experience within the Biopharmaceutical / device industry. Previous experience within the areas of Manufacturing and/or Quality Assurance is considered to be an asset.

12+ years experience in a Quality Organization in an FDA CBER/CDER and EMA regulated industry.

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.

Experience and passion to build, lead and mentor a cross-functional team with the opportunity to leave a lasting legacy on the team, organization and the country.Experience in leading, developing, coaching and mentoring a cross-functional team.

The ability to develop an overarching CMC/GMP QA strategy and inspire a team to deliver upon AbCellera’s vision and goals.

Demonstrated a strong Quality mindset and ability to influence across the entire organization.Experience in leading, developing, coaching and mentoring a cross-functional team.

Experience in communicating and/or interacting with Regulatory Health Authorities in direct support of IND/BLA submissions and associated facility inspection activities.

Why AbCellera

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.

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