Clinical QA Manager - Audit & Compliance Lead

ClinLab Solutions Group; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

ClinLab Solutions Group is seeking a Manager, Quality Assurance to ensure adherence to established QM processes and provide objective evidence of compliance. The role focuses on continuous improvement of QM processes and procedures across the organization.

The Manager, QA will oversee customer and partner audit activities, coordinate responses to auditors, and actively contribute to QA programs such as CAPA, deviation control, document management, and internal audits, including inspections and

Qualifications

• 5-10 years of experience in clinical quality within a regulated industry.
• BS or MS in a related science.

Responsibilities

• Oversee the customer and partner audit program, including scheduling, preparations, hosting, and follow-up for audits.
• Assist QA senior management in defining ongoing enhancements to the Customer Audit program.
• Coordinate audit responses and deliver audit responses to external auditors.
• Implement, maintain, and contribute to QA-managed programs (CAPA, Deviation, Document Management, Internal Quality System Audit).
• Support activities related to customer and partner regulatory inspections and internal/regulatory inspections of the company.
• Assist with core product Validation activities.
• Develop and maintain strategic measurement systems for quality and product.
• Support requests from Sales, Operations, and other departments (RFP/RFI responses, contract reviews).

Skills

Interpersonal skills

Communication skills

Presentation skills

Technical issue resolution

Senior management interface

Influence others

Customer focus

Self-directed

Education

BS or MS in a related science

Job description

ClinLab Solutions Group is seeking a Manager, Quality Assurance to ensure adherence to established QM processes and provide objective evidence of compliance. The role focuses on continuous improvement of QM processes and procedures across the organization.

The Manager, QA will oversee customer and partner audit activities, coordinate responses to auditors, and actively contribute to QA programs such as CAPA, deviation control, document management, and internal audits, including inspections and