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QA Validation Manager, Equipment and Instruments

2 weeks ago

Vancouver, Canada AbCellera Biologics Full time

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.