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Quality Systems Manager

5+ years
Not Disclosed
10 April 29, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

Quality Systems Manager


Company:

EVERSANA
Location: Memphis, TN, USA
Department: Corporate – Quality
Job Type: Full-Time | On-site


About the Company:

EVERSANA is a leading global provider of commercialization services for the life sciences industry. With 7,000+ employees and over 650 clients, the company is committed to innovation, regulatory compliance, and improving patient outcomes. EVERSANA promotes diversity, equity, and inclusion and has been certified as a Great Place to Work.


Job Summary:

The Quality Systems Manager is responsible for developing, implementing, and managing Quality Management Systems (QMS) for warehouse and distribution operations. This includes ensuring regulatory compliance, driving continuous improvement, overseeing document control, and leading audits and CAPA processes.


Key Responsibilities:

Quality System Oversight

  • Implement and maintain compliant QMS aligned with warehouse and distribution operations.

  • Lead SOP development and updates.

Regulatory Compliance

  • Ensure adherence to FDA, DEA, NABP, and other relevant standards.

  • Coordinate audits and regulatory inspections.

Quality Metrics & Reporting

  • Track KPIs and quality performance indicators.

  • Report quality metrics to senior management.

Continuous Improvement

  • Lead CAPA initiatives, risk assessments, and root cause analyses.

  • Drive systemic improvements across processes.

Training & Supervision

  • Conduct QMS and regulatory training through LMS.

  • Mentor and guide direct reports.

Cross-functional Collaboration

  • Partner with IT, Operations, Supply Chain, etc., to integrate QMS.

  • Act as a subject matter expert for quality systems.

Document Control & CAPA

  • Manage quality documentation lifecycle.

  • Oversee non-conformance investigations and corrective actions.


Job Expectations:

  • Travel: Up to 10% (for audits)

  • Hours: Full-time (40+ hours/week as needed)

  • Work Environment: Office-based, prolonged sitting, lifting up to 25 lbs


Qualifications:

Minimum:

  • Education: Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field (or equivalent experience)

  • Experience: 5+ years in quality roles (warehouse, distribution, lab, or manufacturing)

  • Skills: Strong communication, attention to detail, and Microsoft Office proficiency

Preferred:

  • Experience: 7+ years in Quality Assurance

  • Certifications: ASQ or similar industry certifications

  • Tools: eQMS, Warehouse Management Software, advanced Excel