Responsibilities
- Establish and manage a Quality Management System compliant with standards such as ISO 9001, ISO 13485, 21 CFR Part 11, and GAMP 5
- Create and update quality-related documentation, including standard operating procedures, validation protocols, and work instructions
- Lead validation of software systems to meet regulatory requirements for industries like pharmaceuticals, biotechnology, and medical devices
- Collaborate with Sales and Customer Success teams to address quality-related inquiries in sales cycles, including RFPs and compliance questionnaires
- Prepare for and manage customer audits, acting as the primary internal contact for quality and regulatory topics
- Oversee supplier quality processes, including evaluation and approval of third-party vendors
- Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency
- Develop training programs to promote quality awareness and best practices across the company
