Quality Assurance Manager
Greenville/Spartanburg/Anderson, SC
We are seeking an experienced Quality Assurance Manager to lead and strengthen our Quality Assurance function within a highly regulated manufacturing environment. This role is ideal for a quality professional with experience in the food, dietary supplement, nutraceutical, pharmaceutical, or related GMP-regulated industry who is passionate about quality systems, compliance, continuous improvement, and operational excellence.
The Quality Assurance Manager will oversee all aspects of the Quality Assurance Department, including audits, document control, GMP compliance, training programs, complaint management, CAPA processes, validation activities, and SOP development. This individual will partner closely with Operations, Regulatory Affairs, and Leadership to ensure products consistently meet regulatory and customer requirements.
Key Responsibilities
Quality Systems & Compliance
- Lead and maintain company-wide Quality Management System (QMS) programs.
- Ensure compliance with FDA regulations, current Good Manufacturing Practices (cGMP), and internal quality standards.
- Develop, implement, review, and continuously improve quality policies and procedures.
- Create, revise, and maintain Standard Operating Procedures (SOPs).
Audits & CAPA Management
- Plan, coordinate, and lead internal and external audits.
- Support customer, supplier, and regulatory inspections.
- Drive corrective and preventive action (CAPA) investigations and monitor effectiveness.
- Prepare audit reports and ensure sustainable corrective actions are implemented.
Complaint & Quality Reporting
- Oversee customer complaint investigations and complaint registry management.
- Ensure timely responses and CAPA submissions to customers.
- Analyze quality metrics and trends to identify opportunities for improvement.
- Prepare quality performance reports and present findings to operations leadership.
Validation & Continuous Improvement
- Develop and oversee process, equipment, and cleaning validation/verification programs.
- Lead quality improvement initiatives across manufacturing operations.
- Partner with cross-functional teams to improve product quality, efficiency, and compliance.
Team Leadership
- Supervise and develop quality compliance and validation personnel.
- Lead GMP initiatives and foster a culture of quality throughout the organization.
- Conduct GMP training and support employee development programs.
Qualifications
Education & Experience
- Bachelor's degree in Quality, Food Science, Microbiology, Chemistry, Biology, Pharmaceutical Sciences, Engineering, or a related field; equivalent experience may be considered.
- Minimum of 2-5 years of Quality Assurance leadership experience in:
- Food Manufacturing
- Dietary Supplements
- Nutraceuticals
- Pharmaceuticals
- Medical Devices
- Other FDA-regulated manufacturing environments
Preferred Experience
- Strong understanding of FDA regulations and quality systems.
- Experience supporting FDA, customer, and third-party audits.
- Proven success leading CAPA investigations and compliance programs.
- Experience managing validation and verification activities.
Knowledge, Skills & Abilities
- Working knowledge of 21 CFR Part 111, 21 CFR Part 110, cGMP requirements, and quality systems.
- Strong leadership, organizational, and problem-solving skills.
- Excellent written and verbal communication skills.
- Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Access).
- Ability to work effectively in a manufacturing environment with noise, airborne powders, and moving equipment.
Pay: $75,000.00 - $100,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Vision insurance
Work Location: In person
