Head of Quality

  • Permanent
  • Dublin

Website Ref:TPM04359

Summary:
A start up Biologics Company based in south Dublin is looking to hire a Head of Quality to provide vision, leadership, and direction to the Quality team. The incumbent will be a key member of the business leadership team, working closely with other business leaders to ensure that the company maintains the highest possible standards from a Quality perspective.

Responsibilities:

  • 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.
  • Responsible for the recruitment, development, coaching needs of the direct Quality team and building a high-performance culture supporting embedding a quality mindset in the company.
  • 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.
  • Operation and maintenance of the Document Management system to ensure control of SOPs, records, and other documents.
  • 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.
  • Establishment and maintenance of robust document & record retention / storage process.
  • Responsible for ensuring the business is well-positioned to meet all business, safety, customer, and process requirements.
  • 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 Regulatory Services capability.
  • Support the development of a new QC GMP Analytical Services capability.
  • Provide leadership of Lean / continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
  • Provide leadership for the integration of digital solutions to ensure compliant and efficient operations.
  • Provide leadership for the development of effective training programmes (process and product), and programmes to assure focus on problem prevention as well as detection.
  • Execution of assigned projects (design and otherwise) within cost and schedule requirements including the company initiatives lean, safety and cost reduction.
  • Work with operations and other stakeholders within the group to develop best practices in all aspects of Quality Management.
  • Collaborate with other departments and represent Manufacturing in cross functional initiatives and meetings.

Qualifications & Experience:

  • Relevant degree.
  • 10 -15 years 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.
  • 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 (HPRA, US-FDS, EU and non-EU Authorities) is essential.
  • Strong knowledge of regulatory requirements, i.e. GMP, Health Canada, EU, and FDA and experience with GMP documentation review is essential.
  • Experienced in hosting customer audits and certification audits.
  • Good interpersonal skills with the ability to influence others across multiple functions.
  • Ability to work both strategically and creatively, to implement innovative Quality systems & processes.
  • Leadership capability will be reflected by your desire to invest in and develop team members and to support their continued personal and professional growth.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.