Qc Validation Manager

4 weeks ago

Shannon, Ireland Hobson Prior Full time

Hobson Prior is seeking a QC Method Transfer Manager to join a leading biotech organization on an exciting fixed-term contract, driving excellence in analytical processes and quality standards.
In this role, you'll lead method lifecycle activities supporting advanced biologic products, ensuring GMP compliance across sites in Ireland and the UK.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
Lead the development, optimization, and transfer of analytical methods supporting gene therapy programs.
Serve as the key technical expert for analytical procedures, lab instrumentation, and material oversight.
Prepare and maintain documentation to support analytical activities in line with regulatory and compliance standards.
Oversee the rollout of test methods to meet project milestones and support product commercialization.
Ensure all external testing activities adhere to current GMP regulations.
Provide training to team members on newly introduced technologies and methodologies.
Conduct routine assessments of analytical methods to confirm ongoing effectiveness and compliance.
Support the upkeep of the Quality Management System and uphold data integrity standards.
Monitor and achieve key performance indicators (KPIs) and project objectives within defined timelines.
Ensure timely and compliant completion of team training requirements.
Manage GMP documentation, including resolution of issues, CAPA implementation, and audit follow-up actions.
Key Skills and Requirements:
Background in health sciences or equivalent experience in a regulated industry (e.g., biology, pharmaceuticals).
Experience in a validation role within a regulated environment.
Proven ability to manage a team and deliver projects on time.
Knowledge of EU and FDA regulations, GMP, and quality standards.
Strong organizational skills with the ability to handle multiple projects simultaneously.
Familiarity with lean manufacturing and Six Sigma principles is a plus.
Enthusiastic, goal-oriented, and adaptable to a fast-paced work environment.
For more information, please contact
Grant Van Schalkwyk
.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.
Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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