Manager of Quality Management Systems

Advanced Recruiting Partners; Garner (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

A staffing and recruiting company is looking for a Manager of Quality Management Systems in North Carolina. This role involves overseeing QMS processes, ensuring compliance with regulatory requirements, and managing audits. Candidates should have a minimum of 5 years of experience in the pharmaceutical or life sciences industry, along with strong communication and organizational skills. The role requires proficiency in quality management tools and offers a full-time position with an emphasis on compliance and operational excellence.

Qualifications

• Minimum of 5 years of experience in a Quality Management Systems role in pharmaceuticals or life sciences.
• Results-oriented and effective communication skills are essential.
• Experience with electronic QMS platforms preferred.

Responsibilities

• Oversee and manage QMS processes in compliance with standards.
• Conduct internal and external audits of warehouse operations.
• Lead deviation management, including investigations and CAPAs.

Skills

Customer service mindset

Effective communication skills

Time management

Organizational skills

Problem-solving skills

Education

Master's degree preferred

Tools

SAP

MS Office

Google Workspace

Job description

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The Manager, Quality Management Systems (QMS) is responsible for ensuring compliance with Good Distribution Practices (GDP), 21 CFR regulations, and other applicable standards within a warehouse environment supporting clinical trial supplies. This role leads the implementation, maintenance, and continuous improvement of quality systems to ensure regulatory compliance, operational excellence, and inspection readiness.

Essential Duties and Responsibilities

• Oversee and manage QMS processes, including document control, policy development, and procedure implementation, in alignment with GDP, 21 CFR, and industry standards.
• Plan, conduct, and manage internal and external audits of warehouse operations to ensure compliance with regulatory requirements, quality guidelines, and standard operating procedures (SOPs).
• Lead deviation management, including investigations, corrective and preventive actions (CAPAs), change control activities, and risk assessments.
• Ensure timely vendor and customer qualification and verification activities.
• Verify accuracy and completeness of quality documentation for all inbound and outbound transactions executed by warehouse operations.
• Maintain accurate, current, and compliant records within the electronic QMS (eQMS) for all quality-related documentation and activities.
• Review, approve, and authorize quality-related documents, records, and agreements.
• Prepare, review, and maintain SOPs, validation documentation, training records, and other quality documents within the eQMS to ensure compliance with regulatory and organizational standards.
• Support regulatory inspections, internal audits, and customer audits by providing documentation, addressing findings, and ensuring inspection readiness.
• Monitor QMS performance using metrics and reports to assess effectiveness and identify opportunities for improvement.
• Develop and deliver training programs for staff on QMS processes, GDP requirements, and regulatory compliance.
• Collaborate with cross-functional teams, including warehouse operations, logistics, and regulatory functions, to resolve quality issues and implement improvements.
• Train warehouse operations personnel on quality procedures and compliance expectations.
• Stay current with evolving regulatory requirements and ensure timely incorporation into QMS practices.
• Conduct annual reviews of SOPs and update processes as required.
• Ensure all quality and operational documents are maintained in a controlled, secure, and compliant manner.

Qualifications

• Minimum of 5 years of experience in a Quality Management Systems role within the pharmaceutical or life sciences industry.
• Results‑oriented professional with a strong customer service mindset and effective communication skills.
• Experience with SAP and electronic QMS platforms preferred.
• High attention to detail with professional verbal and written communication skills.
• Ability to manage multiple priorities and projects simultaneously in a regulated environment.
• Willingness and ability to travel for audits, meetings, and industry events.
• Strong time management, organizational, and problem‑solving skills.
• Self‑motivated, accountable, and proactive in driving quality initiatives.
• Proficient in administrative tools, including MS Office and Google Workspace.
• Excellent written, verbal, and interpersonal communication skills.

Masters is preferred.

Seniority Level

• Associate

Employment Type

• Full‑time

Job Function

• Science

Industries

• Staffing and Recruiting