Connecting...

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

 

Why Apply Through Sigmar?

  • We’ll help manage your job hunt, strengthen your interview skills and tidy up your CV
  • We’ll provide you with an overview of the jobs market within your industry and help you tailor your jobs search
  • Gain access to exclusive roles that are not advertised elsewhere

 

 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.