Quality Manager | ClinLab Staffing

The Quality Assurance (QA) Manager is responsible for ensuring Client’s Quality Management Systems are of the highest quality by maintaining and improving compliance to procedures, policies, and guidelines.


  • Manage the electronic Quality Management System (eQMS) (MasterControl)
  • Serve as a resident Quality expert in support of QMS activities (GLP, GCP, and CLIA)
  • Serve as the System administrator for eQMS system
  • Configure and implement Process and Auditing modules to expand usage of the system
  • Author and review departmental SOPs, as well as, review non-departmental SOPs
  • Provide day-to-day management of document control processes and workflows within the EDMS
  • Manage any regulatory or governing body certifications (CLIA)
  • Manage change control, CAPA, deviation, and investigation programs
  • Review and approve executed documents including validation documents, reports that could be filed in support of regulatory submissions, and operating procedures.
  • Oversee the internal and external audit program, which includes, focus on GxP, GLP, GCP, CLIA compliance, regulatory agency inspection readiness, and for-cause inspections
  • Provide support to Clinical Team and Laboratory to ensure compliance with GCP’s, GLPs and applicable regulatory requirements
  • Work with clinical operations and regulatory affairs to review submission documents.
  • Directly interface with Clinical Operations to provide support for vendor, site and internal GCP audits.
  • Perform and/or support audits of clinical sites, CROs and other clinical vendors.
  • Review and approve audits to ensure GCP compliance.
  • Assist in the development of Quality Agreements with GCP vendors.
  • Oversee and/or conduct CQA review of clinical protocols and reports.
  • Maintain relationships with vendors, contractors, and consultant to ensure effective execution of assigned tasks.
  • Facilitate vendor management
  • Build and manage department budget
  • Responsible for facilitation and maintenance training records
  • Responsible for records management and facilitation of off-site records storage.
  • Identify, develop, and communicate a metrics (KPI) system to drive awareness and improvement measurement
  • Other duties, as assigned.


  • Requires a Bachelor’s (Master’s degree preferred) in a related scientific discipline with 10-15 years’ experience in QA in a GxP regulated environment
  • Must have successful implementation experience and management of a QMS System
  • Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, and 312.
  • Must demonstrate attention to detail and excellent record keeping skills
  • Must be proficient in MS Office Suite (e.g. Word, Excel, PPT) required for review and preparation of documents and reports for inspections
  • Proven ability to find creative, practical solutions to complex problems
  • Excellent communication and interpersonal skills
  • Superior and proven organizational skills
  • Ability to multitask and work in a team-oriented fast-paced environment
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To apply for this job email your details to info@clinlabstaffing.com