Sr Quality Manager

Location: Lancaster, SC
Department: Quality Assurance
Reports To: Director of Quality

Summary of the Role

The Senior Quality Manager (SQM) is responsible for developing and deploying quality systems across manufacturing and laboratory operations. This role ensures that systems and procedures comply with government regulations, industry standards, and internal specifications. The SQM works closely with operations and other quality leaders to align material handling, equipment cleaning, and room cleaning with process flows in manufacturing and packaging environments, including oversight of contract manufacturing organizations (CMOs).

Key Responsibilities

• Maintain a strong understanding of GMP requirements and regulations related to dietary supplement manufacturing and preventive controls for animal food (21 CFR Part 111 and 21 CFR Part 507).
• Ensure quality processes related to manufacturing and packaging, including cleaning procedures across all facilities.
• Collaborate with operations management to ensure work instructions are appropriate for each work center.
• Align batch records with work instructions and on-the-job training (OJT), and oversee in-process quality checks for all product formats (e.g., tablets, capsules, powders, liquids, soft chews, pellets).
• Establish standards where necessary to support quality and compliance.
• Partner with supply chain teams to manage raw material release and availability for manufacturing operations.
• Lead internal and external audits related to the microbiology laboratory and contribute to strategic responses to audit findings.
• Lead or oversee investigations related to manufacturing operations.
• Serve as the Management Representative for Quality when required.
• Develop and implement quality systems such as CAPA, design control, and process control to ensure product conformity.
• Manage quality compliance for CMOs and regulatory inspections.
• Communicate effectively across departments and contribute to a collaborative team environment.
• Perform other duties as assigned to support company objectives.

Minimum Requirements

• Strong understanding of quality control testing and quality assurance processes.
• Thorough knowledge of FDA, USP, AOAC, and ICH guidelines.
• Experience implementing and maintaining GLP/GMP compliance in pharmaceutical or nutritional supplement manufacturing.
• Effective interpersonal and communication skills across all organizational levels.
• Demonstrated problem-solving and cross-functional team leadership abilities.

Education & Experience

• Bachelor's degree in Chemistry, Microbiology, or a related science field.
• Minimum of 10 years of experience in quality control and assurance within the pharmaceutical or nutritional supplement industry.
• Laboratory management experience is required.

Supervisory Responsibilities

This role includes direct supervision of quality staff.

Safety & Incident Management Responsibilities

• Enforce safe work practices and procedures to prevent workplace accidents.
• Promptly correct unsafe or unhealthful conditions within scope of authority; implement temporary measures when immediate correction is not possible.
• Train and remind employees to identify and report hazards.
• Respond to incidents by ensuring first aid is administered, securing the scene, and arranging further medical treatment if needed.
• Notify environmental health and safety (EHS) for incidents requiring medical attention.
• Ensure completion of safety incident reports and initiate investigations.
• Coordinate with EHS to conduct root cause analysis using tools such as 5 WHY; implement corrective actions agreed upon by the cross-functional team.
• Submit completed investigations to the incident reporting team.