Director - Quality Systems and Compliance

Director, Quality Systems and Compliance- Waltham, MA

Job Summary

The Director, Quality Systems & Compliance will play a lead role in the further development and management of the Quality Management System in accordance with applicable global regulatory requirements and business objectives. This is a high visibility position that will play a critical role in partnering with our parent company.

Responsibilities

• Oversight for companywide GxP training programs, ensuring a clear line of sight from training requirements to specific GxP job functions aligned to job descriptions
• Lead the further development, execution, and maintenance of all aspects of the (internal and external) audit and inspection readiness programs
• Participate in the continuous improvement of the inspection readiness program and implementation of additional initiatives
• Develop, review, and ongoing monitoring of quality agreements and associated contracts
• Ownership of the GxP Training, Supplier Management, and GxP documentation systems
• Assist with the execution of the Quality Management Review process, including oversight of analysis and reporting of Quality System and supplier performance metrics
• Ownership of the supplier qualification program, inclusive of audit planning, logistics, and audit execution over the general GxP landscape
• Foster cross-functional collaboration to execute ongoing risk assessments of contracted service providers to ensure accurate classification and handling of suppliers
• Develop, monitor, and improve quality processes which are scalable and sustainable to meet the growing needs of the organization
• Foster a quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions
• Assist with presenting the management review of quality compliance and operational KPIs to ensure the identification of and timely mitigation of unfavorable trends

Qualifications