Job Type
Full-time
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.
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
