Quality Manager

About the role

Join ABEC, a global leader in biopharmaceutical manufacturing solutions, as the Quality Manager for our Fermoy, Ireland site. You will lead and mentor the onsite Disposable Container (DC) manufacturing Quality team while driving quality initiatives that support operational excellence, regulatory compliance, and customer satisfaction in a fast-paced, innovative manufacturing environment.

Responsibilities

• Lead, coach, and develop a team of Quality professionals.
• Foster a culture of accountability, continuous improvement, and operational excellence.
• Ensure adequate cross-training and team readiness to support internal and external quality requirements.
• Drive efficiency, productivity, and performance across the Quality function.
• Oversee and evaluate team performance through coaching, development, and performance management.
• Ensure compliance with ABEC Standard Operating Procedures (SOPs), quality systems, and industry best practices.
• Support and maintain quality processes aligned with cGMP, GDP, ISO standards, and applicable regulatory requirements.
• Participate in internal, external, vendor, and customer audits.
• Manage and support CAPA activities, including root cause analysis and corrective/preventive action implementation.
• Lead Continuous Improvement initiatives that enhance processes, quality outcomes, and operational efficiencies.
• Coordinate Quality System Change Management activities.
• Oversee site calibration programs and quality system documentation.
• Monitor, analyze, and report key quality metrics and performance indicators.
• Support Material Review Board (MRB) processes and trend analysis activities.
• Partner with cross-functional teams to achieve site objectives and business goals.
• Support company core values, key initiatives, and strategic quality objectives.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• 5+ years of experience in Quality, Validation, or a related field within a manufacturing environment.
• Prior leadership experience managing and developing quality teams.
• Strong knowledge of cGMP, ISO 9000, or equivalent quality systems.
• Ability to travel domestically and internationally as needed.

Preferred Qualifications

• Experience leading teams of 10+ Quality professionals.
• Experience reporting and analyzing site quality KPIs and metrics.
• ASQ Certified Quality Engineer (CQE), Certified Quality Manager (CQM), Six Sigma, or related certifications.
• Experience in life sciences, pharmaceutical, biotechnology, or regulated manufacturing environments.

Benefits

At ABEC, you'll have the opportunity to make a meaningful impact in a company that helps enable the production of life-saving therapies around the world. We offer a collaborative culture, opportunities for professional growth, and the chance to lead critical quality initiatives that support operational and customer success.