Global Quality Leader — Disposable & Single-Use Tech

ABEC Inc; Bethlehem (Northampton County); Vor Ort; USD 150.000 - 210.000; Vollzeit

Benefits dieser Stelle

Medical, dental and vision insurance (

3 weeks Paid vacation

Industry leading 401K plan (40% match)

10 Paid Holidays

Company paid life insurance

College tuition benefit program

Employee Referral Program

Zusammenfassung

ABEC Inc. is seeking a Global Director of Quality to lead the Disposable/Single-Use Quality team and ensure top-tier quality across our global operations.

This executive role focuses on quality programs, team development, audits, and continuous improvement in the biopharmaceutical space. You will partner with cross-functional teams, drive operational excellence, and support customer audits while traveling as needed to global sites.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Leadership

Quality systems

Audits

Ausbildung

Bachelor's degree in Engineering, Life Sciences, or related field

Tools

ASQ certifications

Six Sigma

Quality KPI reporting

Jobbeschreibung

ABEC Inc. is seeking a Global Director of Quality to lead the Disposable/Single-Use Quality team and ensure top-tier quality across our global operations.

This executive role focuses on quality programs, team development, audits, and continuous improvement in the biopharmaceutical space. You will partner with cross-functional teams, drive operational excellence, and support customer audits while traveling as needed to global sites.