Quality Manager

ABEC; Bethlehem (Northampton County); On-site; USD 101,000 - 134,000; Full time

Job summary

ABEC is seeking a Quality Manager to lead the onsite Disposable Container (DC) manufacturing Quality team at our Fermoy, Ireland site. You will guide quality initiatives, ensure regulatory compliance, and partner with cross-functional teams to support operational excellence and customer satisfaction.

This is a critical leadership role in a fast-paced, life sciences manufacturing environment. The ideal candidate has a Bachelor’s degree in Engineering or Life Sciences, 5+ years in quality within

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 5+ years in Quality/Validation within manufacturing.
• Experience leading quality teams.
• Knowledge of cGMP and ISO quality systems.
• Willingness to travel domestically and internationally.

Responsibilities

• Lead and develop the onsite Quality team toward excellence.
• Ensure compliance with cGMP, ISO 9000, and ABEC SOPs.
• Drive continuous improvement and CAPA activities.
• Coordinate audits and quality metrics reporting.

Skills

Quality leadership

cGMP compliance

Auditing & CAPA

Regulatory standards

Cross-functional leadership

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Quality Manager

Lead Quality Excellence in a Growing Life Sciences Manufacturing Environment

Are you a quality-driven leader with a passion for continuous improvement, compliance, and developing high-performing teams? Join ABEC, a global leader in biopharmaceutical manufacturing solutions, and play a critical role in ensuring world-class quality standards across our manufacturing operations. 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. This is an exciting opportunity to influence quality strategy, improve processes, and partner with cross-functional teams in a fast-paced, innovative manufacturing environment.

• 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.

Required Qualifications

• 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.

Why Join ABEC?

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.