Head of Quality

Job description

About Your New Employer

  • Innovative start-up with a focus on critical specialised medicines
  • You will be based in a state-of-the-art Biologics facility supporting exciting expansions

About Your New Job

  • Responsible for developing and executing a quality assurance vision that incorporates outstanding Quality Assurance standards and QC testing approaches.
  • Leadership of Quality Department to ensure development and reporting of quality metrics, delivery of business & departmental goals.
  • The Head of Quality is responsible for the recruitment, development, coaching needs of the direct Quality team and building a high-performance culture supporting embedding a quality mindset
  • Responsible for the development, implementation, and management of a QMS for our GMP activities which will ensure we deliver on the compliance & licensure requirements of regulatory agencies and create a positive reputation.
  • Management of quality systems such as Deviation, CAPA, Change Control, Training, Complaints, Internal Audit, Vendor Management, and Risk Management to ensure compliance & escalation as appropriate.
  • Development of our GMP QC analytical capability or function
  • Responsible for ensuring the business is well-positioned to meet all business, safety, customer, and process requirements.
  • As Head of Quality you will be responsible for keeping senior Leadership informed about regulatory status of the business and significant regulatory issues
  • Support the vendor qualification program including initial and ongoing qualification to ensure quality oversight of GxP Vendors.
  • Co-ordinate approval of suppliers, customers, and activities such as Bona Fide checks.
  • Execute internal audit process and lead the organization during all third-party audits, notified body and regional authority.
  • Develop a holistic strategy to apply appropriate standards across both GMP Manufacturing and non-GMP Process Development activities.
  • Support the development of a new QC GMP Analytical Services capability or function
  • Execution of assigned projects (design and otherwise) within cost and schedule requirements including the company initiatives lean, safety and cost reduction.

What Skills You Need

  • The Head of Quality should have 10 of experience in GMP manufacturing, Quality Assurance / Quality Control, with at least 5 years in a leading position, preferably in areas that include QA, quality systems, auditing, compliance, tech transfer / new product introduction.
  • You should have a strong understanding of quality management systems and GMP is required; GDP experience an advantage but not essential.
  • Experience in Drug Substance, Biologicals, and Drug Products is essential.
  • Experience with managing & hosting regulatory inspections  is essential.


What’s on Offer

  • Permanent position with an innovative and exciting start-up
  • Excellent basic salary on offer
  • You will play a pivotal role in the growth of the Quality function offering excellent learning & progression opportunities


What’s Next​

  • Apply now by clicking the “Apply Now" button or call me, Ryan Malone on 086 771 8408.​ Or if the job isn’t quite right but you are looking for something similar, please get in touch


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