Global Quality Leader - Disposable & Single-Use Tech

Abec,-Inc.

Bethlehem (Northampton County)

On-site

USD 150,000 - 210,000

Full time

14 days+

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Benefits offered by this job

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

Job summary

ABEC is seeking an experiencedGlobal Director of Quality to lead the 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

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.

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

Leadership
Quality management
cGMP knowledge
ISO 9000 knowledge
Six Sigma

Education

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

Job description

ABEC is seeking an experiencedGlobal Director of Quality to lead the 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

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