Collins McNicholas

Job Title: Head of QA, GMP | Global Pharma | Ireland 

Role Description:

Head of Quality for a Global Biopharmaceutical company based in Ireland. The role will head up Quality for the manufacturing site in Ireland, overseeing all aspects of product quality. The ideal person would be a certified Qualified Person with proven line management experience and will oversee the senior leadership team. This role will be responsible for leading and directing all of the site quality organisation and functions and will report into the Global VP of QA.

Role Responsibilities:  

  • Acts as primary QP for the site: Primary interface with global regulatory authority as it relates to site inspections, management of product issues/market action, product registration response to questions.
  • Position holder reports directly to global QA for the Pharma and Biologics division of the business and acts as primary interface on all quality compliance related activities and initiatives with the global QA team.
  • Responsible for batch release, facility quality system and product quality assurance: Including;
  • Management of QC Inspection, Microbiology and Chemistry laboratories (Stability & Commercial Release)
  • Site Regulatory Compliance group activities: Risk Management, Quality Metrics Monitoring and management review, implementation of company global policies; monitoring and implementation of new and changes to existing regulatory standards and directives
  • Management of the Quality Management Systems: Deviations, CAPA program and Out of Specifications (OOS);
  • Oversight of cleanroom activities for sterile aseptically manufactured and terminally sterilised product streams
  • Oversight of the facility change control program
  • Management of Site Customer Compliant Process
  • Ownership of the self-inspection and supplier audit programs
  • Facilitation of regulatory inspections; liaising with health authorities globally
  • Management of Site GMP training program
  • Control of site quality and laboratory expenditure and capital budgets
  • Quality oversight of engineering changes, new equipment, facility changes and new product introduction/product transfer
  • Embedding Operational excellence principles across the quality function, including lean labs principles
  • Member of the site leadership team involved in the overall management of the site including
    • Involvement in site strategic programs in terms of future capital and site facility expansions
    • Assessment of site projects through the approval of capital expenditure from a quality perspective
    • Management of quality function operating budgets and capital expenditure
    • Participation in Environment, Health and Safety site programs for Quality Function
    • Recruitment and structure of key skills for delivery of an effective team 

 

Role Requirements: 

  • A BSc or MSc in Life Sciences or Ph.D.
  • Certified Qualified Person as per Directive 2001/83/EC for Medicinal products for human use.
  • Experience heading up Quality Assurance within a pharmaceutical manufacturing setting.
  • Proven line manager overseeing and managing various functional groups within a significant manufacturing setting in pharmaceuticals
  • Ideally have experience with Biologics (not a prerequisite)
  • Extensive Quality Operations experience within a QA GMP setting within pharmaceuticals or biopharmaceuticals.
  • Experience hosting and overseeing Regulatory Inspections.

  

For a confidential discussion and more information on the role, please contact Courtney Russell on 071 910 8062 or email courtney.russell@collinsmcnicholas.ie

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