Design, Qualification & Validation (DQV) Manager
We are seeking a senior and permanent Design, Qualification & Validation (DQV) Manager to join our team at a rapidly expanding Biotech Manufacturing company based in Cork.
About the Role
This is a key position with responsibility for the management of the DQV team as the company continues to expand its capabilities.
The successful candidate will play a pivotal role in the continued development and strategic direction of the business, driving innovation in the biopharma industry while collaborating across quality, engineering, and production teams.
Core Responsibilities:
* Management and execution of the Master Validation Schedule
* Management of product drawing execution and qualification
* Management of Sub-Supplier Component specification & Qualification
* Alignment of Customer User Requirement Specification and Compliance
* Collaborating extensively with the Engineering team in the continued development of both existing and new products introductions.
* Cross-Functional Collaboration with the Quality and various site Teams.
* Participating in investigations, change management and complaints as required
* Participating in Audits
Requirements:
* Educational Background: Degree in Process, Biotechnology, or related Engineering field.
* Experience: 8+ years' experience working in a GMP environment across Quality and / or Validation.
* Strong experience managing product lifecycles in a dynamic environment.
* Project management experience (lead out and delivery)
* Analytical and Strategic Thinking: Ability to assess and problem solve
* Communication Skills: Ability to communicate complex concepts clearly and effectively.
* Problem-Solving: Exceptional collaboration and problem-solving abilities.
About Us
We are a rapidly expanding Biotech Manufacturing company based in Cork, committed to driving innovation in the biopharma industry while maintaining the highest standards of quality and compliance.