Senior Director of Quality Assurance
1 month ago
AbCellera is seeking a highly skilled and experienced Senior Director of Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.
Key Responsibilities- Provide exceptional leadership to the Quality Assurance team, including hiring, mentoring, and developing staff.
- Design and implement quality systems, including vendor/supplier selection, qualification, and governance processes, internal/external audit programs, and quality risk management.
- Develop and provide lifecycle management of the Quality Management System (QMS), including deviations, change controls, CAPA, Annual Product Quality Review (APQRs), audit and inspection management programs, complaint management, recalls, etc.
- Collaborate with internal/external/partner cross-functional teams to ensure the timely and compliant progression of projects in accordance with approved project plans.
- Author and review CMC INDs, BLAs, and other relevant regulatory dossier sections, and strategize to support responses to regulatory questions during review period and product lifecycle.
- Develop, implement, and monitor phase-appropriate GxP and compliance systems, procedures, and policies.
- Lead the Quality Assurance department program progression from lead candidate selection through pre-clinical, IND, and/or commercial readiness (BLA) activities.
- Review and approve manufacturing and testing records, and perform the QA release function.
- Bachelor's degree or equivalent and 15+ years of experience within the biopharmaceutical or device industry.
- 12+ years of experience in a quality organization in an FDA CBER/CDER and EMA regulated industry, with previous experience in manufacturing or quality assurance.
- 6+ years of experience building, leading, developing, coaching, and mentoring a cross-functional team.
- Experience implementing phase-appropriate quality systems supporting CMC through IND/BLA in compliance with applicable regulations, guidelines, and industry best practices.
- Ability to develop an overarching CMC/GMP QA strategy and inspire a team to deliver upon AbCellera's vision and goals.
- Strong quality mindset and ability to influence across the entire organization.
- Self-motivated and able to identify project needs and follow up with building and implementing solutions.
- Passionate about building dynamic new teams and capabilities that accomplish important goals.
- Bias towards innovation over industry standards.
AbCellera is a global company that discovers and develops antibody-based medicines that help people live longer, happier, and more productive lives. We are focused on bringing innovative medicines to patients, both by advancing our internal pipeline of programs and partnering with companies that have novel science or innovative technology.
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.
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director of Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director of Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director, Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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4 weeks ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director, Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Senior Director of Quality Assurance
1 month ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director of Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Senior Director of Quality Assurance
1 month ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director of Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Senior Director of Quality Assurance
1 week ago
Vancouver, British Columbia, Canada AbCellera Full timeSenior Director, Quality AssuranceAbCellera is a global company that discovers and develops antibody-based medicines to help people live longer, happier, and more productive lives. We are looking for a motivated Quality leader to become the Senior Director, Quality Assurance. This role will be responsible for building a team and designing quality systems to...
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Senior Director of Quality Assurance
1 month ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly experienced Senior Director, Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Senior Director of Quality Assurance
1 month ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director, Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Senior Director of Quality Assurance
1 month ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director, Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Senior Director of Quality Assurance
3 weeks ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director of Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Senior Director of Quality Assurance
1 month ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly experienced Senior Director, Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Senior Director of Quality Assurance
3 weeks ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director of Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly experienced Senior Director, Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team to ensure the development and delivery of high-quality products that meet regulatory requirements.Key...
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Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly experienced Senior Director, Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team to ensure the development and delivery of high-quality products that meet regulatory requirements.Key...
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Senior Director of Quality Assurance
4 weeks ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly experienced Senior Director, Quality Assurance to lead the development and implementation of quality systems that meet the company's audacious goal of going from Discovery to fill-finish in a year.Key ResponsibilitiesProvide exceptional leadership to the organization, including hiring, mentoring, and developing...
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Senior Director of Quality Assurance
4 weeks ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly experienced Senior Director, Quality Assurance to lead the development and implementation of quality systems that meet the company's audacious goal of going from Discovery to fill-finish in a year.Key ResponsibilitiesProvide exceptional leadership to the organization, including hiring, mentoring, and developing...
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Senior Director of Quality Assurance
4 weeks ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director of Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
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Senior Director of Quality Assurance
4 weeks ago
Vancouver, British Columbia, Canada AbCellera Full timeAbout the RoleAbCellera is seeking a highly skilled and experienced Senior Director of Quality Assurance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance team, designing and implementing quality systems, and ensuring compliance with regulatory requirements.Key...
