Bachelor's degree in Engineering, Life Sciences, or related field
5+ years of Quality or Validation experience in a manufacturing environment
Leadership experience with proven success in team development
Strong knowledge of cGMP, ISO 9000, or similar quality standards
Preferred certifications include ASQ, Six Sigma, and quality KPI reporting experience
Responsibilities
Lead, coach, and develop the global Disposable/Single-Use 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 starting from Day 1
3 weeks paid vacation
Industry leading 401K plan with a 40% match
10 paid holidays
Company-paid life insurance
College tuition benefit program
Employee Referral Program
Full Job Description
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.
