Clinical Quality Assurance Manager

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.

This is a newly created role. The hiring manager currently manages the majority of QA operational activities herself. This person will take on the bulk of the day-to-day QA workload described below, allowing Julia to focus on managing client escalations and higher-level QA strategy. Given the fast-moving, lean nature of the team, this role requires someone who can manage their own schedule and workload independently, and who Julia can trust to take ownership without close oversight.

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.

? Supplier evaluation/audit 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.

• 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 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).

JOB QUALIFICATIONS

Education & Training:

• 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.