Quality Manager

ABEC; Wilson (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision insurance (

Company paid life insurance

3 weeks paid vacation

10 paid holidays

Generous 401K plan (40% match)

College tuition benefit program

Employee Referral Program

Job summary

ABEC in Wilson, NC is seeking a Quality Manager to lead the onsite Disposable Container (DC) manufacturing Quality team and drive quality initiatives that support operational excellence and regulatory compliance. You will influence quality strategy, improve processes, and partner with cross-functional teams in a fast-paced manufacturing environment.

The role requires strong leadership, deep knowledge of cGMP/ISO standards, and a proven track record in quality management within life sciences

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• 5+ years of experience in Quality, Validation, or a related field within a manufacturing environment.
• Prior leadership experience managing and developing quality teams.
• Strong knowledge of cGMP, ISO 9000, or equivalent quality systems.
• Ability to travel domestically and internationally as needed.

Responsibilities

• Lead, coach, and develop a team of Quality professionals.
• Foster a culture of accountability, continuous improvement, and operational excellence.
• Ensure adequate cross-training and team readiness to support internal and external quality requirements.
• Drive efficiency, productivity, and performance across the Quality function.
• Oversee and evaluate team performance through coaching, development, and performance management.
• Ensure compliance with ABEC SOPs, quality systems, and industry best practices.
• Support quality processes aligned with cGMP, GDP, ISO standards, and regulatory requirements.
• Participate in internal, external, vendor, and customer audits.
• Manage CAPA activities including root cause analysis and corrective/preventive action implementation.
• Lead Continuous Improvement initiatives enhancing processes and efficiencies.
• Coordinate Quality System Change Management activities.
• Oversee site calibration programs and quality system documentation.
• Monitor, analyze, and report key quality metrics and KPIs.
• Support MRB processes and trend analysis.

Skills

Leadership experience

Quality management

cGMP knowledge

ISO standards

Education

Bachelor's degree in Engineering or Life Sciences

ASQ CQE / CQM / Six Sigma certification

Job description

Quality Manager

Lead Quality Excellence in a Growing Life Sciences Manufacturing Environment

, a global leader in biopharmaceutical manufacturing solutions, and play a critical role in ensuring world-class quality standards across our manufacturing operations.

you will lead and mentor the onsite Disposable Container (DC) manufacturing Quality team while driving quality initiatives that support operational excellence, regulatory compliance, and customer satisfaction. This is an exciting opportunity to influence quality strategy, improve processes, and partner with cross-functional teams in a fast-paced, innovative manufacturing environment.

• Lead, coach, and develop a team of Quality professionals.
• Foster a culture of accountability, continuous improvement, and operational excellence.
• Ensure adequate cross-training and team readiness to support internal and external quality requirements.
• Drive efficiency, productivity, and performance across the Quality function.
• Oversee and evaluate team performance through coaching, development, and performance management.
• Ensure compliance with ABEC Standard Operating Procedures (SOPs), quality systems, and industry best practices.
• Support and maintain quality processes aligned with cGMP, GDP, ISO standards, and applicable regulatory requirements.
• Participate in internal, external, vendor, and customer audits.
• Manage and support CAPA activities, including root cause analysis and corrective/preventive action implementation.
• Lead Continuous Improvement initiatives that enhance processes, quality outcomes, and operational efficiencies.
• Coordinate Quality System Change Management activities.
• Oversee site calibration programs and quality system documentation.
• Monitor, analyze, and report key quality metrics and performance indicators.
• Support Material Review Board (MRB) processes and trend analysis activities.
• Partner with cross-functional teams to achieve site objectives and business goals.
• Support company core values, key initiatives, and strategic quality objectives.

Description

Quality Manager

Lead Quality Excellence in a Growing Life Sciences Manufacturing Environment

Are you a quality-driven leader with a passion for continuous improvement, compliance, and developing high-performing teams? Join ABEC, a global leader in biopharmaceutical manufacturing solutions, and play a critical role in ensuring world-class quality standards across our manufacturing operations.

As the Quality Manager for our Wilson, NC site, you will lead and mentor the onsite Disposable Container (DC) manufacturing Quality team while driving quality initiatives that support operational excellence, regulatory compliance, and customer satisfaction. This is an exciting opportunity to influence quality strategy, improve processes, and partner with cross-functional teams in a fast-paced, innovative manufacturing environment.

What You'll Do

• Lead, coach, and develop a team of Quality professionals.
• Foster a culture of accountability, continuous improvement, and operational excellence.
• Ensure adequate cross-training and team readiness to support internal and external quality requirements.
• Drive efficiency, productivity, and performance across the Quality function.
• Oversee and evaluate team performance through coaching, development, and performance management.
• Ensure compliance with ABEC Standard Operating Procedures (SOPs), quality systems, and industry best practices.
• Support and maintain quality processes aligned with cGMP, GDP, ISO standards, and applicable regulatory requirements.
• Participate in internal, external, vendor, and customer audits.
• Manage and support CAPA activities, including root cause analysis and corrective/preventive action implementation.
• Lead Continuous Improvement initiatives that enhance processes, quality outcomes, and operational efficiencies.
• Coordinate Quality System Change Management activities.
• Oversee site calibration programs and quality system documentation.
• Monitor, analyze, and report key quality metrics and performance indicators.
• Support Material Review Board (MRB) processes and trend analysis activities.
• Partner with cross-functional teams to achieve site objectives and business goals.
• Support company core values, key initiatives, and strategic quality objectives.

What We're Looking For

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related discipline.
• 5+ years of experience in Quality, Validation, or a related field within a manufacturing environment.
• Prior leadership experience managing and developing quality teams.
• Strong knowledge of cGMP, ISO 9000, or equivalent quality systems.
• Ability to travel domestically and internationally as needed.

Preferred Qualifications

• Experience leading teams of 10+ Quality professionals.
• Experience reporting and analyzing site quality KPIs and metrics.
• ASQ Certified Quality Engineer (CQE), Certified Quality Manager (CQM), Six Sigma, or related certifications.
• Experience in life sciences, pharmaceutical, biotechnology, or regulated manufacturing environments.

Why Join ABEC?

At ABEC, you\'ll have the opportunity to make a meaningful impact in a company that helps enable the production of life-saving therapies around the world. We offer a collaborative culture, opportunities for professional growth, and the chance to lead critical quality initiatives that support operational and customer success.

Ready to lead quality excellence? Apply today and help shape the future of biopharmaceutical manufacturing.

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, 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 (benefits start day 1)
• Company paid life insurance
• 3 weeks paid vacation
• 10 paid holidays
• Generous 401K plan (40% match)
• College tuition benefit program
• Employee Referral Program