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 a track record of team development.
Strong understanding of cGMP, ISO 9000, or equivalent quality standards.
Preferred ASQ certifications, Six Sigma, and quality KPI reporting knowledge.
Responsibilities
Lead, coach, and develop the global Disposable/Single-Use Quality team.
Drive initiatives focused on quality, compliance, and continuous improvements.
Oversee audits, CAPA investigations, change management, and vendor qualifications.
Ensure adherence to SOPs, GDP, cGMP, and quality system standards.
Coordinate calibration, product qualification, and equipment validation activities.
Monitor quality metrics and report updates to senior leadership.
Support customer audits and collaborate with global site stakeholders.
Benefits
Medical, dental and vision insurance effective on Day 1.
Three weeks of paid vacation.
Industry-leading 401K plan with a 40% match.
Ten paid holidays annually.
Company-paid life insurance coverage.
College tuition benefit program.
Employee referral program incentives.
Full Job Description
Job Type
Full-time
Description
Global Director of Quality - Disposable & Single-Use Technologies
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.
