Description
I have an immediate opening for Validation Manager with a world leading medical device company based in Cork.This position is responsible for the development, management and leadership of Validation group and requires a candidate with strong commercial & financial acumen as well as strong people management experience.
Role:
* Providing direction on Validation strategy and direction for the group.
* Overall responsibility for Validation master plan.
* Overall project Management of Validation projects.
* The review and approval key validation related documents.
* Validation performance evaluation through Key Performance Indicators (KPI) and continuous improvement for highest efficiency of Regulatory Affairs operation.
* Integrate, contribute, and/or lead cross-functional project teams as required.
* Collaborate with internal and external partners, vendors, contractors, as required.
* Lead and manage the validation group.
* Demonstrated knowledge of current regulatory requirements pertaining to validation within a medical device environment.
* The ability to continually adapt to a changing regulated environment and provide direction and guidance to best practices in validation management and execution.
* Good financial acumen and understanding of the requirements to manage the group within the financial constraints of a business.
* Demonstrated ability to lead teams to complete activities in effective and efficient manner.
* Possess highly developed interpersonal skills.
* Be competent in meeting customer's requirements whilst managing their overall expectations.
* Strong report writing and presentation skills are essential.
* A working knowledge of Statistical techniques and analysis.
* Extensive experience in defending Validation during regulatory inspections.
* Current knowledge, experience and/or proven interest in efficient and integrated approaches to Validation / Change Control.
* Lean and Six Sigma training would be advantage.
Requirements:
* Bachelor's Degree in Science, Engineering or related subject.
* 8+ years experience in GMP manufacturing environment in Engineering, Quality or Validation Medical Device/Pharma background.
* Demonstrated track record in delivering an efficient and integrated approach to validation management and execution.
If you are interested in hearing more about this opportunity please apply directly to this advert for immediate consideration or contact Derek Sheridan for further information.