Overview of Role:

The QP Manager will be responsible for ensuring the compliant release of pharmaceutical products in accordance with EU Good Manufacturing Practice (GMP), European Medicines Agency (EMA) regulations, and Irish Health Products Regulatory Authority (HPRA) requirements. The role will focus on leading remote batch release activities, ensuring timely and compliant certification of medicinal products manufactured globally.

Role and Responsibilities:

• Act as a Qualified Person (QP) as per EU Directive 2001/83/EC to certify the release of medicinal products
• Oversee remote batch release operations, ensuring real-time quality oversight of manufacturing and testing conducted at global contract manufacturing organizations (CMOs) and contract testing laboratories (CTLs)
• Ensure compliance with EU GMP, ICH guidelines, HPRA, and EMA regulatory requirements
• Manage batch documentation reviews and approvals using digital QMS platforms and electronic batch records (EBRs)
• Collaborate with CMOs, CDMOs, and supply chain partners to ensure seamless remote certification and product release
• Provide leadership on quality assurance (QA) and quality management system (QMS) initiatives
• Conduct audits of CMOs, CDMOs, and suppliers to ensure compliance with GMP standards.
• Act as the primary quality contact for regulatory inspections, audits, and remote review processes
• Support deviation investigations, CAPA implementation, and change control processes.
• Provide training and mentorship to junior QA team members
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• BSc/MSc/PhD in Pharmaceutical Sciences, Chemistry, Biology, or related discipline
• Legally eligible to act as a QP under EU Directive 2001/83/EC.
• Minimum 5+ years of experience in a GMP-regulated environment within the pharmaceutical or biotechnology industry
• Experience in remote batch release, electronic batch records (EBRs), and digital QMS systems
• Strong knowledge of EU regulatory requirements, HPRA/EMA expectations, and GMP compliance for global supply chains
• Experience working with CMOs/CDMOs and managing outsourced manufacturing.
• Proven ability to lead and influence in a cross-functional, global team setting
• Strong problem-solving skills and ability to manage complex quality issues remotely