Quality Systems Manager

PHIBRO ANIMAL HEALTH CORP; Sligo; Presencial; EUR 90.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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

Responsabilidades

• 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

Conocimientos

Quality leadership

Regulatory compliance

GMP knowledge

Audits & inspections

Cross-functional collaboration

Data analysis

Process improvement

Educación

Advanced degree in Biological/Pharmaceutical science

Herramientas

MS Office

Descripción del empleo

About Phibro Animal Health Corporation

Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.

Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro’s revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide.

At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.

TheQuality Systems Manageris an integral part of our Qualityteam based out of our Ireland - Sligosite.

The Quality Systems Lead is responsible for the effective management, maintenance, and continuous improvement of the site's Pharmaceutical Quality System (PQS) to ensure compliance with GMP, regulatory requirements, and company standards. This role provides leadership and oversight of key quality systems including deviations, CAPA, change control, complaints, quality risk management, document control, training, audit management, and management review processes

Essential Roles and Responsibilities:

• 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 European Union (EU) Veterinary Medicinal Products regulations related to Veterinary Medicinal Products and Continuous improvement.
• Decision Making/Problem Solving - Identify and understand issues, problems and opportunities and compare data from different sources to draw conclusions and develop solutions consistent with the facts. Natural influencer and ability to form strong relationships cross functionally.
• Correct weaknesses, ineffective procedures, and discrepancies and performs or approves appropriate corrective actions
• Write, review, and revise Standard Operating Procedures (SOPs)
• Provides Training to new employees.
• Able to work effectively with team members and other professionals such as vendors, contractors, or suppliers with the aim of ensuring their products or services meet the organization’s quality standards
• Support departmental objectives and strategic initiatives.
• Proficiency with Microsoft applications, including Word and Excel and environmental systems.
• Other duties as assigned

Education and or Work Experience Requirements:

• 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 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

Specialized Knowledge or Skills:

• Proficient in quality principles in a manufacturing facility with a strong quality mindset and proactive approach.
• Must be able to work under pressure and meet deadlines, while maintaining a positive attitude.
• Have good communication skills and able to collaborate effectively.
• Effective time management; deliver results on time.
• Excellent computer proficiency (MS Office – Word, Excel, Power Point and Outlook).
• Has the ability to read, write and communicate in English.

Phibro is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.

Business Unit:Animal Health & Mineral Nutrition
Division:Animal Health & Nutrition
Department:Quality
Location:Ireland - Sligo
Work Schedule:Monday - Friday (40 Hours)