The Role:

Nuvalent is searching for a dynamic Associate Director, Quality Systems to join our growing Quality team. The Associate Director, Quality systems will be responsible for supporting multi-functional teams on electronic system implementations, problem resolution, and process improvement projects. This Quality Assurance processional will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. The role will report to the Senior Director, Quality Assurance. 

Responsibilities:

• Oversees quality management systems to support training, procedural document lifecycle, and record retention for all GxP functions.
• Evaluation of existing Quality Management System processes for the identification of potential gaps to regulatory requirements.
• Responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements
• Acts as system business owner for the electronic Document Control system and Learning Management System
• Monitoring the performance of the Quality Management System. This includes formally tracking compliance to the established quality standards, monitoring the effectiveness, and establishing a continuous improvement program.
• Maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program
• Interacting with internal departments to support the development of new quality management systems that support GxP activities
• Working effectively in a matrix environment to prioritize, develop, and implement plans to address these gaps and ensure sustained compliance.
• Performing internal and external vendor audits and gap assessments as needed to support Nuvalent data integrity, vendor qualification, and inspection readiness initiatives 

Competencies:

• Ability to drive and deliver on multiple projects within project scope and timelines
• Cross- functional collaboration
• Excellent communication skills

Qualifications:

• Bachelor’s Degree in a Scientific or Engineering discipline
• 8 years’ experience of Quality Assurance experience related to computerized systems with IT compliance/validation/qualification activities
• Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.
• Demonstrated experience, results, and accomplishments in QMS and LMS system implementations
• Experience with Veeva vault required