QA Validation Manager, Facilities & Utilities
AbCellera is breaking the barriers of conventional antibody drug discovery to bring better medicines to patients, sooner. AbCellera’s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.
AbCellera is in search of a QA Validation Manager for cGMP Facilities and Utilities who can lead quality oversight of validation activities and/or execute QA validation deliverables for these areas.
The position provides guidance and hands-on support for multiple, complex validation projects, ensuring all qualification and validation activities adhere to regulatory requirements, industry standards, and the AbCellera Site Validation Master Plan and associated procedures.
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!
We’d love to hear from you if
- You are a passionate leader who can motivate, inspire, and build highly effective teams while managing for high performance and the development of others.
- You have management experience overseeing validation activities for facilities and utilities, work well within cross-functional teams, and have experience providing QA oversight and support for the planning of commissioning, qualification, and validation activities.
How you might spend your days
- Leading, managing, coaching/mentoring, training, and developing the QA Validation team responsible for facilities and equipment
- Establishing and maintaining quality validation processes, procedures, and practices
- Reviewing and approving commissioning and qualification documents for facilities, utilities, processes, and computer systems in accordance with the site Validation Master Plan and Commissioning, Qualification, and Validation Procedures.
- BS, BA, or equivalent degree preferably in the Sciences or Engineering field, 8+ years related work experience, including 3+ years of direct management of a technical validation team
- A working knowledge of applicable regulatory standards, such as GCP, GMP, GDP, GLP, USP, ANSI, ISO, ASTM, OHSA, and ICH.
- Strong knowledge of data governance/integrity requirements including 21 CFR Part 11, Annex 11, FDA Draft Guidance: Computer Software Assurance, and other industry standards is also necessary.
- Experience in authoring/reviewing/approving validation documentation
- Demonstrated ability and willingness to apply critical thinking and effective risk-based decision making, and excellent communication skills are also required.