Quality Compliance Supervisor

Ajulia Executive Search; Rock Hill (SC); On-site; USD 80,000 - 120,000; Full time

Job summary

Ajulia Executive Search is seeking a Quality Compliance Supervisor in Rock Hill, SC to oversee the complaints program and site compliance under FDA regulations. You will supervise QA staff, support audits, and ensure 21 CFR compliance across manufacturing and quality systems.

The role requires 5+ years in cGMP and customer service within FDA-regulated industries, with travel up to 30%. Proficiency in MS Office and QA software is essential.

Qualifications

• B.A. or B.S. in Science or Technical field.
• Minimum 5 years in a cGMP environment and 5 years in customer service within FDA-regulated industry.
• Knowledge of 21 CFR Parts 210, 211, 507, and 111.
• Proficiency in MS Office and QA software systems.
• Ability to stand, walk, and work in manufacturing/cleanroom environments with PPE.
• Willingness to travel 20-30% domestically (international travel may be required).

Responsibilities

• Supervise customer complaints and QA compliance operations.
• Monitor customer feedback and report product issues.
• Respond to escalated inquiries and assist in investigations.
• Support counterfeit product investigations when required.
• Oversee batch record reviews and manage quality systems (Complaints, Non-conformance, Audit, Supplier).
• Track and trend complaints, non-conformances, and CAPAs; elevate risks when needed.
• Oversee product returns related to complaints.
• Maintain QA compliance presence in manufacturing, packaging, and laboratory operations.
• Develop performance indicators and compliance reporting.
• Support change control and participate in audits (UL, NSF, ISO, FDA).
• Train internal teams on quality and compliance expectations.
• Communicate effectively across departments and promote a positive team environment.

Skills

cGMP

Customer service

Quality assurance

Education

B.A./B.S. in Science or Technical field

Tools

MS Office

QA software systems

Job description

The Quality Compliance Supervisor oversees the complaints program and site compliance activities under FDA regulations. This role ensures product quality, safety, and compliance with 21 CFR requirements while supervising QA staff and supporting audits.

Key Responsibilities

• Supervise customer complaints and QA compliance operations.
• Monitor customer feedback and report product issues.
• Respond to escalated inquiries and assist in investigations.
• Support counterfeit product investigations when required.
• Oversee batch record reviews and manage quality systems (Complaints, Non-conformance, Audit, Supplier).
• Track and trend complaints, non-conformances, and CAPAs; elevate risks when needed.
• Oversee product returns related to complaints.
• Maintain QA compliance presence in manufacturing, packaging, and laboratory operations.
• Develop performance indicators and compliance reporting.
• Support change control and participate in audits (UL, NSF, ISO, FDA).
• Train internal teams on quality and compliance expectations.
• Communicate effectively across departments and promote a positive team environment.

Requirements

• B.A. or B.S. in Science or Technical field.
• Minimum 5 years in a cGMP environment and 5 years in customer service within FDA-regulated industry.
• Knowledge of 21 CFR Parts 210, 211, 507, and 111.
• Proficiency in MS Office and QA software systems.
• Ability to stand, walk, and work in manufacturing/cleanroom environments with PPE.
• Willingness to travel 20-30% domestically (international travel may be required).