Senior Director of Quality Assurance

1 day ago

Vancouver, British Columbia, Canada AbCellera Full time
About the Role

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.
Requirements
  • 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.
  • 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.
What We Offer

AbCellera offers a competitive salary range of $190,000 - $235,000, annually, commensurate with education and job-related knowledge, skills, and experience. We also offer equity, annual bonus dependent on team and company performance, and 6% (non-match) RRSP contribution. Additionally, we provide a $1,500 annual active lifestyle allowance, professional development opportunities, and comprehensive health benefits.

About AbCellera

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.

  • Director of Care and Quality Assurance

    1 week ago

    Vancouver, British Columbia, Canada Humans of HR, Vancouver Full time

    Job Description**About Humans of HR, Vancouver**We are a boutique recruitment agency in Vancouver, dedicated to providing exceptional talent to our clients. Our team is passionate about delivering outstanding results and building long-lasting relationships.**Job Title:** Director of Care and Quality Assurance**Job Summary:** We are seeking an experienced...

  • Director of Care and Quality Assurance

    1 week ago

    Vancouver, British Columbia, Canada Humans of HR, Vancouver Full time

    Job Description**About Humans of HR, Vancouver**We are a boutique recruitment agency in Vancouver, dedicated to providing exceptional talent to our clients. Our team is passionate about delivering outstanding results and building long-lasting relationships.**Job Title:** Director of Care and Quality Assurance**Job Summary:** We are seeking an experienced...

  • Senior Director of Quality Assurance

    7 days ago

    Vancouver, British Columbia, Canada AbCellera Full time

    About the RoleAbCellera is a global biopharmaceutical company that discovers and develops antibody-based medicines. We are seeking a highly experienced Senior Director of Quality Assurance to join our team.Key ResponsibilitiesLead the development and implementation of quality systems to support the company's growth and expansion.Build and manage a...

  • Senior Director of Quality Assurance

    7 days ago

    Vancouver, British Columbia, Canada AbCellera Full time

    About the RoleAbCellera is a global biopharmaceutical company that discovers and develops antibody-based medicines. We are seeking a highly experienced Senior Director of Quality Assurance to join our team.Key ResponsibilitiesLead the development and implementation of quality systems to support the company's growth and expansion.Build and manage a...

  • Senior Director, Quality Assurance and Compliance

    1 week ago

    Vancouver, British Columbia, Canada AbCellera Full time

    About the RoleAbCellera is seeking a highly experienced and skilled Senior Director, Quality Assurance and Compliance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance and Compliance team to ensure the highest standards of quality and regulatory compliance across our...

  • Senior Director, Quality Assurance and Compliance

    1 week ago

    Vancouver, British Columbia, Canada AbCellera Full time

    About the RoleAbCellera is seeking a highly experienced and skilled Senior Director, Quality Assurance and Compliance to join our team. As a key member of our organization, you will be responsible for building and leading a high-performing Quality Assurance and Compliance team to ensure the highest standards of quality and regulatory compliance across our...

  • Senior Director, Quality Assurance

    2 weeks ago

    Vancouver, British Columbia, Canada Central 1 Full time

    About the Role:The Senior Director, Quality Assurance will spearhead the mission to fortify the integrity of the Finance team's operations, meticulously crafting and supervising robust internal control mechanisms. In this pivotal capacity, they will serve as the driving force behind the achievement of strategic finance objectives, skillfully maneuvering...

  • Senior Director, Quality Assurance

    2 weeks ago

    Vancouver, British Columbia, Canada Central 1 Full time

    About the Role:The Senior Director, Quality Assurance will spearhead the mission to fortify the integrity of the Finance team's operations, meticulously crafting and supervising robust internal control mechanisms. In this pivotal capacity, they will serve as the driving force behind the achievement of strategic finance objectives, skillfully maneuvering...

  • Senior Director, Quality Assurance

    4 weeks ago

    Vancouver, British Columbia, Canada AbCellera Full time

    AbCellera is a global company dedicated to discovering and developing antibody-based medicines that improve people's lives. We are driven by a team of scientists, engineers, creatives, and business professionals who believe in the power of science to enhance well-being. Our focus lies in unlocking high-value drug targets, including antibody-drug conjugates...

  • Senior Quality Assurance Analyst

    2 weeks ago

    Vancouver, British Columbia, Canada Royal Bank of Canada Full time

    About the RoleWe are seeking a highly motivated Senior Quality Assurance Analyst to join our team at the Royal Bank of Canada. As a Senior Quality Assurance Analyst, you will be responsible for driving automation testing initiatives within the program under the direction of overall Quality Assurance vision and strategy.Key ResponsibilitiesMain point of...

  • Senior Quality Assurance Analyst

    2 weeks ago

    Vancouver, British Columbia, Canada Royal Bank of Canada Full time

    About the RoleWe are seeking a highly motivated Senior Quality Assurance Analyst to join our team at the Royal Bank of Canada. As a Senior Quality Assurance Analyst, you will be responsible for driving automation testing initiatives within the program under the direction of overall Quality Assurance vision and strategy.Key ResponsibilitiesMain point of...

  • Quality Assurance Software Engineer

    1 month ago

    Vancouver, British Columbia, Canada Integral Senior Living Full time

    About the RoleIntegral Senior Living is seeking a dedicated and skilled Quality Assurance Software Engineer to enhance our software development processes. Our team comprises industry experts and innovators committed to delivering exceptional solutions.Key ResponsibilitiesDevelop and execute comprehensive test plans and test cases.Utilize tools such as...

  • Quality Assurance Director

    2 weeks ago

    Vancouver, British Columbia, Canada Electronic Arts Full time

    About Electronic ArtsElectronic Arts is a global leader in digital interactive entertainment. Our mission is to inspire creativity and innovation in the gaming industry. We strive to create immersive and engaging experiences for millions of players around the world.About the RoleWe are seeking an experienced Quality Assurance Director to lead our Quality...

  • Quality Assurance Director

    2 weeks ago

    Vancouver, British Columbia, Canada Electronic Arts Full time

    About Electronic ArtsElectronic Arts is a global leader in digital interactive entertainment. Our mission is to inspire creativity and innovation in the gaming industry. We strive to create immersive and engaging experiences for millions of players around the world.About the RoleWe are seeking an experienced Quality Assurance Director to lead our Quality...

  • Senior Manager, Quality Assurance Specialist

    7 days ago

    Vancouver, British Columbia, Canada Immigrant Services Society of BC Full time

    Job Title: Senior Manager, Quality AssuranceWe are seeking a highly skilled and experienced Senior Manager, Quality Assurance to join our team at Immigrant Services Society of BC. As a key member of our organization, you will play a critical role in accelerating the development and implementation of quality improvement processes, knowledge, and activities...

  • Senior Manager, Quality Assurance Specialist

    7 days ago

    Vancouver, British Columbia, Canada Immigrant Services Society of BC Full time

    Job Title: Senior Manager, Quality AssuranceWe are seeking a highly skilled and experienced Senior Manager, Quality Assurance to join our team at Immigrant Services Society of BC. As a key member of our organization, you will play a critical role in accelerating the development and implementation of quality improvement processes, knowledge, and activities...

  • Senior Manager, Quality Assurance

    2 weeks ago

    Vancouver, British Columbia, Canada Immigrant Services Society of BC Full time

    Job Title: Senior Manager, Quality AssuranceWe are seeking a highly skilled and experienced Senior Manager, Quality Assurance to join our team at the Immigrant Services Society of BC (ISSofBC) Vancouver Welcome Center.Job Summary:The Senior Manager, Quality Assurance will be responsible for ensuring the quality of our services and programs, and will work...

  • Senior Manager, Quality Assurance

    2 weeks ago

    Vancouver, British Columbia, Canada Immigrant Services Society of BC Full time

    Job Title: Senior Manager, Quality AssuranceWe are seeking a highly skilled and experienced Senior Manager, Quality Assurance to join our team at the Immigrant Services Society of BC (ISSofBC) Vancouver Welcome Center.Job Summary:The Senior Manager, Quality Assurance will be responsible for ensuring the quality of our services and programs, and will work...

  • Director of Quality Assurance

    2 weeks ago

    Vancouver, British Columbia, Canada Viva Recruiters Full time

    Job Opportunity Overview:We are seeking a Director of Quality Assurance to spearhead our firm-wide quality management initiatives from a remote position within British Columbia or Alberta. This role is integral to enhancing our quality assurance, ethics culture, and compliance with the latest industry standards. The ideal candidate will bring a wealth of...

  • Director of Quality Assurance

    2 weeks ago

    Vancouver, British Columbia, Canada Viva Recruiters Full time

    Job Opportunity Overview:We are seeking a Director of Quality Assurance to spearhead our firm-wide quality management initiatives from a remote position within British Columbia or Alberta. This role is integral to enhancing our quality assurance, ethics culture, and compliance with the latest industry standards. The ideal candidate will bring a wealth of...