Quality Manager
About the Role
Join ABEC, a global leader in biopharmaceutical manufacturing solutions, 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 role offers the opportunity to influence quality strategy, improve processes, and partner with cross-functional teams in a fast-paced, innovative manufacturing environment.
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 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.
Requirements
- 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.
Benefits
- 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.
About the Company
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.