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.
Why Join ABEC?
At ABEC, quality is more than compliance—it's a commitment to excellence that directly supports the production of critical therapies around the world. As our Global Quality Manager, you'll have the opportunity to influence global operations, lead meaningful improvements, and help build innovative solutions that make a real difference in patients' lives.
If you're a collaborative leader with a passion for quality, continuous improvement, and developing high-performing teams, we'd love to hear from you.
Apply today and help shape the future of biopharmaceutical manufacturing quality.
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Company Background: For over 50 years, ABEC has been a leading supplier to the biopharmaceutical manufacturing industry. ABEC’s unique value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to reduce overall cost, shorten time to market, and maximize productivity. ABEC’s products include process and equipment engineering/consulting services, comprehensive site services, and stainless steel and single use bioprocess equipment, including bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilization systems.
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
Skills Required
- Bachelor's degree in Engineering, Life Sciences, or related field
- 5+ years Quality or Validation experience in a manufacturing environment
- Leadership experience with proven success developing teams
- Strong knowledge of cGMP, ISO 9000, GDP, and SOPs
- Experience overseeing audits, CAPA investigations, change management, and vendor qualifications
- Experience coordinating calibration, product qualification, and equipment validation activities
- ASQ certifications
- Six Sigma
- Quality KPI reporting experience
What We Do
ABEC engineered solutions and services for biotech manufacturing Since 1974, ABEC has been a global leader in delivering integrated process solutions and services for manufacturing in the biopharmaceutical industry. Many of today’s leading antibody, vaccine, and recombinant protein therapies are manufactured by processes and equipment engineered, manufactured, installed and serviced by ABEC, and a majority of the world’s pharmaceutical and biotech companies are ABEC customers. ABEC’s unique value is based on long experience, complete in-house capabilities, a custom, flexible approach, and long-term credibility. Whether building new capacity or improving existing facilities, ABEC’s turn-key solutions reduce overall cost and time to market while delivering maximum productivity. For more information, please visit www.abec.com or email [email protected] Interested in a career at ABEC? Learn more about our open positions at https://www.abec.com/join-our-team/
