Clinical QA Manager

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

The Manager, Quality Assurance is responsible for assuring that established Quality Management (QM) processes are being followed and that there is objective evidence of that compliance. The Manager, QA is dedicated to continuous improvement of QM processes and procedures supporting the organization.

Responsibilities:

• Oversee the customer and partner audit program, including:
• Assist QA senior management in defining ongoing enhancements to the Customer Audit program.
• Managing and tracking the scheduling, preparations, hosting, and follow-up for customer and partner audits, including hands-on involvement in and support for such audit-related activities.
• Helping QA senior management define the model for and deliver coaching to other departments who are actively participating in customer and partner audits.
• Coordinating audit responses and preparing and delivering audit response to external auditors.
• Implement, maintain, and actively contribute to QA-managed programs, including:
• Corrective and Preventive Action (CAPA) program.
• Quality System Deviation program.
• Quality System Document Management program.
• Internal Quality System Audit program (in coordination with department-led operational self-assessments).
• Assist QA senior management with activities related to customer and partner regulatory inspections, and internal audits and regulatory inspections of company itself.
• Assist with core product Validation activities.
• Assist in the development, management, and maintenance of strategic measurement systems for the company, particularly for quality and product.
• Help support and track requests from Sales, Operations, and other departments within company related to quality and regulatory requests from customers and partners, including:
• RFP/RFI responses.
• Contract reviews (focusing on quality and regulatory requirements/adherence).
• Support requests from QA management related to the department's business operations (e.g., metrics, status updates).

Qualifications:

• 5-10 years of experience in clinical quality, within a pharmaceutical company, technology company, EDC company, or other regulated industry; eCOA-specific experience is not required.
• BS or MS in a related science.

Key Skills:

• Excellent interpersonal and communication skills.
• Excellent written and oral presentation skills.
• Proven experience in dealing with technical issues.
• Proven ability to interface with senior level management.
• Demonstrated ability to influence others outside of span of control.
• Strong orientation towards customer and service quality.
• Highly self-directed and able to manage one's own schedule and workload with minimal oversight.