Quality Systems Lead – EU GMP & Continuous Improvement

PHIBRO ANIMAL HEALTH CORP; Sligo; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Phibro Animal Health Corporation in Ireland - Sligo, seeks a senior Quality Systems Manager Lead to oversee the Pharmaceutical Quality System (PQS), ensuring GMP compliance and regulatory alignment at the Sligo site. You will lead deviations, CAPA, change control, complaints and training, driving continuous improvement across quality processes.

The role requires 6–8 years in biotech/pharma with GMP QA leadership, EU GMP expertise, and strong cross-functional collaboration.

Qualifications

• Minimum 6–8 years of relevant experience in biotech or pharmaceutical industry.
• Minimum 2 to 3 years’ experience managing GMP Quality Systems.
• Prior experience interfacing with and managing inspections performed by regulatory bodies.
• Advanced degree in Biological/Pharmaceutical science discipline.
• Demonstrated success in quality management leadership and the resolution of significant quality/technical challenges.
• Expertise in EU GMP, regulatory inspections, risk-based QA strategies, and digital transformation in quality systems.
• Proven ability to lead teams, optimize QA processes, and drive a culture of continuous improvement.
• Strong working knowledge of Industry Compendia, regulations, and standards including USP / Ph. Eur, GMP, EMA, and ICH

Responsabilités

• Supports and facilitates audits and regulatory inspections.
• Develops, improves, and monitors Quality Systems for the organization.
• Continuously improves areas impacted by deviations and approves appropriate CAPAs.
• Monitor system performance through KPIs and Quality Metrics.
• Drive continuous improvement initiatives across all quality systems.
• Write and revise standard operating procedures (SOPs).
• Provides direction and oversight during active processes and applies understanding of EU Veterinary Medicinal Products regulations.
• Decision Making/Problem Solving - identify issues and develop data-driven solutions.
• Correct weaknesses, ineffective procedures, and performs or approves corrective actions.
• Write, review, and revise SOPs
• Provides Training to new employees.
• Collaborate with vendors, contractors or suppliers to ensure quality of products/services meeting standards
• Support departmental objectives and strategic initiatives.
• Proficiency with MS Office, including Word and Excel.
• Work with team members to meet deadlines under pressure

Connaissances

Quality leadership

Regulatory compliance

GMP knowledge

Audits & inspections

Cross-functional collaboration

Data analysis

Process improvement

Formation

Advanced degree in Biological/Pharmaceutical science

Outils

MS Office

Description du poste

Phibro Animal Health Corporation in Ireland - Sligo, seeks a senior Quality Systems Manager Lead to oversee the Pharmaceutical Quality System (PQS), ensuring GMP compliance and regulatory alignment at the Sligo site. You will lead deviations, CAPA, change control, complaints and training, driving continuous improvement across quality processes.

The role requires 6–8 years in biotech/pharma with GMP QA leadership, EU GMP expertise, and strong cross-functional collaboration.