Global Manager of Quality, Disposable & Single-Use Technologies

ABEC; Bethlehem (Northampton County); On-site; USD 140,000 - 210,000; Full time

Job summary

ABEC seeks a Global Quality Manager to lead the Disposable/Single-Use Quality team and uphold top-tier quality, compliance, and continuous improvement globally. You will mentor a high-performing team, drive operational excellence, support audits and validation activities, and partner with cross-functional teams to strengthen quality systems across the biopharmaceutical industry.

Qualified candidates have 5+ years in Quality or Validation in manufacturing, strong cGMP/ISO 9000 knowledge, and

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 5+ years of Quality or Validation experience in a manufacturing environment.
• Leadership experience with proven success developing teams.
• Strong knowledge of cGMP, ISO 9000, or similar quality standards.
• ASQ certifications, Six Sigma, and quality KPI reporting experience preferred.

Responsibilities

• Lead, coach, and develop the global DC Quality team.
• Drive quality, compliance, productivity, and continuous improvement initiatives.
• Oversee audits, CAPA investigations, change management, and vendor qualifications.
• Ensure compliance with SOPs, GDP, cGMP, and quality system requirements.
• Coordinate calibration, product qualification, and equipment validation activities.
• Monitor quality metrics and provide updates to senior leadership.
• Support customer audits and collaborate with stakeholders across global sites.
• Travel domestically and internationally as needed.

Skills

Quality leadership

cGMP knowledge

ISO 9000 knowledge

Six Sigma

Vendor qualification

Education

Bachelor's degree in Engineering/Life Sciences

Job description

Description

Lead Quality. Drive Innovation. Make a Global Impact.

to lead our Disposable/Single-Use Quality team and ensure the highest standards of quality, compliance, and continuous improvement across our global operations. In this leadership role, you’ll oversee quality programs, mentor and develop a high-performing team, drive operational excellence, support audits and validation activities, and partner with cross-functional teams to strengthen quality systems that support the biopharmaceutical industry worldwide.

• Lead, coach, and develop the global DC Quality team.
• Drive quality, compliance, productivity, and continuous improvement initiatives.
• Oversee audits, CAPA investigations, change management, and vendor qualifications.
• Ensure compliance with SOPs, GDP, cGMP, and quality system requirements.
• Coordinate calibration, product qualification, and equipment validation activities.
• Monitor quality metrics and provide updates to senior leadership.
• Support customer audits and collaborate with stakeholders across global sites.
• Travel domestically and internationally as needed.

Description

Lead Quality. Drive Innovation. Make a Global Impact.

ABEC is seeking an experienced Global Manager of Quality to lead our Disposable/Single-Use Quality team and ensure the highest standards of quality, compliance, and continuous improvement across our global operations. In this leadership role, you’ll oversee quality programs, mentor and develop a high-performing team, drive operational excellence, support audits and validation activities, and partner with cross-functional teams to strengthen quality systems that support the biopharmaceutical industry worldwide.

Key Responsibilities

• Lead, coach, and develop the global DC Quality team.
• Drive quality, compliance, productivity, and continuous improvement initiatives.
• Oversee audits, CAPA investigations, change management, and vendor qualifications.
• Ensure compliance with SOPs, GDP, cGMP, and quality system requirements.
• Coordinate calibration, product qualification, and equipment validation activities.
• Monitor quality metrics and provide updates to senior leadership.
• Support customer audits and collaborate with stakeholders across global sites.
• Travel domestically and internationally as needed.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 5+ years of Quality or Validation experience in a manufacturing environment.
• Leadership experience with proven success developing teams.
• Strong knowledge of cGMP, ISO 9000, or similar quality standards.
• ASQ certifications, Six Sigma, and quality KPI reporting experience are preferred.

Why Join ABEC?

At ABEC, quality is more than compliance—it's a commitment to excellence that directly supports the production of critical therapies around the world. As our Global Quality Manager, you’ll have the opportunity to influence global operations, lead meaning improvements, and help build innovative solutions that make a real difference in patients' lives.

Company Background

For over 50 years, ABEC has been a leading supplier to the biopharmaceutical manufacturing industry. ABEC’s unique value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to reduce overall cost, shorten time to market, and maximize productivity. ABEC’s products include process and equipment engineering/consulting services, comprehensive site services, and stainless steel and single use bioprocess equipment, including bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilization systems.