QA/RA Manager – Galway

  • Reference: GY45341
  • Job Type: Permanent
  • Location: Galway
  • Category: Engineering, Technical & Manufacturing

The Quality Assurance/Regulatory Affairs Manager is the Senior quality position of International Limited reporting to VP EMEA, Quality and Compliance. 

Responsibilities:

  • Possesses and applies a broad expertise of Quality and Regulatory, and its application to contribute to the development of company objectives and maintain a compliant Quality Management System.
  • Possesses advanced knowledge of the organization’s operations and practices to enable informed decisions, and provide direction to Quality team and other functional areas.
  • Responsibility for management of delivery of projects originated in QA or Quality deliverables of business wide projects.
  • Provides point of escalation for Quality impacting business operations.    
  • Operates with business latitude and quality focus.  Determines and develops approach to solutions where situations may have little or no precedent, with new and expanding business operations.  
  • Makes prompt and sound decisions under conditions of uncertainty, that produce effective end results.  Applies risk assessment techniques in such circumstances. 
  • Drives business improvements through management, mentoring and support of the QA Team.
  • Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification. 
  • Maintains quality agreements and collaboration with Third Parties both intercompany and external. 
  • Manages the budget and resources of the department to ensure funds and resources are applied to fulfil the strategic goals of the company.

 

Skills, Experience and Qualifications: 

  • Bsc or equivalent in Lifesciences. 
  • A minimum of 7 years experience with 3-5 years of progressively responsible positions. 
  • A broad knowledge of quality and regulated environments and industry regulators. 
  • Excellent communication skills (both verbal and written).
  • Ability to manage or co-ordinate high performing teams to achieve desired outcomes.
  • A capacity to influence across regions and territories to gain acceptance and accountability of multi-site collaborations.  

For a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

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  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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