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ABEC

Integrated bioprocessing equipment and services.

Quality Manager

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeFermoy, Co. Cork, IrelandNo salary listedIn-person

About the Job

Requirements

  • A bachelor's degree in Engineering, Life Sciences, or a related discipline.
  • At least 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 current Good Manufacturing Practices (cGMP), ISO 9000, or equivalent quality systems.
  • Ability to travel domestically and internationally as needed.

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, Good Documentation Practices (GDP), ISO standards, and applicable regulatory requirements.
  • Participate in internal, external, vendor, and customer audits.
  • Manage and support Corrective and Preventive Action (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.

Desired Qualifications

  • Experience leading teams of 10 or more Quality professionals.
  • Experience reporting and analyzing site quality key performance indicators (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.

About the Company

ABEC

Integrated bioprocessing equipment and services.

ABEC provides integrated biopharmaceutical manufacturing solutions and services to vaccine and therapeutic antibody production, including bioprocess equipment maintenance, troubleshooting, and repairs. It speeds up the design and construction of complete bioprocess lines and delivers customized single-use disposable containers, notably through the Custom Single Run (CSR) product line backed by 45+ years of equipment-design experience. Its approach combines engineering, in-house manufacturing support, and turnkey bioprocessing systems to help clients build, expand, or modify manufacturing capacity with lower upfront costs and faster time to market. ABEC differentiates itself with deep in-house capabilities, global capacity, long-term partnerships, and a focus on production-scale single-use solutions to reduce costs and shorten the path to market for biopharmaceutical manufacturing.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Bethlehem, PA
Founded
1974

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