Global Director of Quality - Disposable & Single-Use Technologies
ABEC Inc•Bethlehem, PA
•Hybrid
About The Position
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.
Requirements
- 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.
Nice To Haves
- ASQ certifications
- Six Sigma
- quality KPI reporting experience
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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
