What You’ll Do:

The Manager of GxP Quality Systems will support Quality Management System processes, procedures, systems, training, and tools, ensuring quality and compliance are achieved and maintained across GxP functions. The role will report to the Senior Manager of GxP Quality Systems.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Track and support closure of Quality Events (e.g., Deviations, CAPAs, etc.)
• Support management of GxP training program, maintenance of GxP training curriculum/matrix, and facilitation and scheduling of GxP trainings
• Conduct Document Control reviews on controlled quality documents and ensure timely periodic reviews and implementation of document change requests
• Support establishment, tracking, measurement, and reporting on metrics for the evaluation effectiveness of the Quality Management Systems
• Support the management of the electronic document management system (Veeva QualityDocs), the electronic learning management system (Veeva Vault Training), and the electronic quality management system (Veeva QMS) as Business Administrator
• Ensure the systems remain in a validated state, documenting changes via IT Change Controls, and executing scripts with evidence
• Evaluate opportunities for continuous improvements across the systems
• Work with stakeholders to ensure appropriate documentation of Service Provider selection, qualification, and evaluation/requalification
• Support development of metrics related to Service Provider qualifications and Service Provider Quality Events
• Manage and track Audit Schedule ensuring adherence to Audit Program and timeliness of deliverables

Required Qualifications:

• Minimum of 6+ years of experience in FDA regulated industry
• Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required
• A strong customer focus and ability to prioritize and adapt to business needs are required
• Strong business partner with all Functional Areas to ensure efficient collaboration and to drive results
• Self-motivated, detail oriented, well-organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
• Ability to resolve day-to-day issues efficiently while maintaining compliance with applicable industry standards
• Clear, concise writing skills and good verbal communication and presentation skills

Education:

• Bachelor’s degree in Life Sciences or a related field