QA Validation Manager, Equipment and Instruments - Vancouver, Canada - AbCellera

AbCellera

Verified Company

Vancouver, Canada

2 weeks ago

Posted by:

Sophia Lee

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Description

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 crossfunctional 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 postqualification procedures like calibration and maintenance.
Ensuring clarity and defensibility of approved validation documents.
Addressing validationrelated investigations and implementing actions.
Representing QA/QC validation in interactions with health authorities.
Driving continuous improvement and goalsetting 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
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 riskbased decisionmaking.
Excellent oral and written communicator.
Expertise in CQV for various QC instruments and equipment.