A leading speciality healthcare company, are looking for an experienced Manager of External Supply Quality Assurance (ESQA Manager) to join the external quality team based out of their South Dublin facility. This innovative organisation has more than 10,000 employees globally, with a generated revenue of $7.7 billion in 2021. They deliver quality medicines, vaccines and diagnostic products, complemented by biodevices and genetic testing across global markets.

The ESQA Manager has responsibility for the oversight of multiple CMOs across Europe, Africa and the Middle East, ensuring global GMP Quality and Regulatory Compliance standards are maintained and the expectations of the business as Marketing Authorization Holder or Distributor are met.

The Role

Duties and responsibilities of the ESQA Manager will include:

Contractor Management:

• Own and manage the contractor relationship for Quality and Regulatory compliance to ensure contractors have applicable quality systems, comply with GMP/regulatory requirements and company expectations for marketed products.
• Routine oversight includes responsibility for Quality Agreements, Change Control, Deviation Management, Market Actions, Lot Approval, Complaint Handling, Annual Product Review, Stability Studies, Validation Approval and Global Compliance Audit Support.

New Product Introduction:

• Support business development opportunities in selection, due diligence audit and evaluation of potential contractors in the process of New Product Introduction by supplying appropriate quality input.

Product Transfers:

• Act as Quality subject matter expert for product transfer teams, advising on company and GMP expectation regarding process validation and analytical method transfers performed at the contractor.

Regulatory Compliance:

• Support and/or conduct Regulatory compliance assessments at contractors.
• Facilitate the process of documentation retrieval and collation to support Marketing Authorization renewals and variations.
• Act as QA focal point for regulatory communications and changes.

ESQA Quality Systems:

• Contribute to the maintenance and development of the ESQA and company Quality Governance models.

The Person

You will have skills and experience in the following:

• BSc in Engineering, Pharmaceutical Science, Microbiology, Chemistry or equivalent
• 10+ years' experience in Pharmaceutical industry supporting manufacturing operation
• Demonstrate knowledge of a range of products and regulatory requirements in the diverse portfolio of medicinal products
• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor. Prepared to take initiatives with an ability to handle and prioritize issues accordingly as they arise
• Ability to prioritize workload to act and work independently, a confident decision maker
• Diplomatic in communication with internal and external stakeholders, strong negotiating skills

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 632 1885 for a confidential discussion.