AbCellera is in search of a QA Validation Manager for cGMP equipment and instruments 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’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 and developing the QA Validation team for QC instruments.
- Establishing and maintaining quality validation processes to meet regulations.
- Collaborating with instrument vendors for validation and troubleshooting.
- Drafting essential QC validation documents and supporting CQV projects.
- Reviewing and approving commissioning and qualification documents.
- Assisting in the post-qualification procedures like calibration and maintenance.
- Ensuring clarity and defensibility of approved validation documents.
- Addressing validation-related investigations and implementing actions.
- Representing QA/QC validation in interactions with health authorities.
- Driving continuous improvement and goal-setting for new programs.
- Collaborating across functions to resolve issues effectively.
- Interfacing with external partners and regulators as needed.
Qualifications
- BS, BA, or equivalent degree preferably in the Sciences or Engineering field, 8+ years Biotech / Pharmaceutical with Quality Compliance or QA Validation related work experience
- Familiarity with GCP, GMP, GDP, and GLP.
- Proficiency in ISPE Baseline Guide Vol 5 and GAMP 5.
- Strong grasp of relevant standards: USP, ANSI, ISO, ASTM, OHSA.
- Knowledgeable about data governance and integrity regulations.
- Experience in creating, reviewing, and approving validation documents.
- Skilled in strategic thinking and risk-based decision-making.
- Excellent oral and written communicator.
- Expertise in CQV for various QC instruments and equipment.
