Global Quality Leader for Disposable & Single-Use Tech

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

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