Global Manager of Quality - Disposable & Single-Use Technologies

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

Description

Lead Quality. Drive Innovation. Make a Global Impact.

ABEC is seeking an experienced Global Director 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 meaningful 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.

Benefits include:

• Medical, dental and vision insurance (Day 1)
• 3 weeks Paid vacation
• Industry leading 401K plan (40% match!)
• 10 Paid Holidays
• Company paid life insurance
• College tuition benefit program
• Employee Referral Program