remote
Senior Manager, Technical SME Standards - Gilead Sciences
Software Engineer
Lead the creation and maintenance of technical standards across product development, driving cross‑functional alignment and ensuring regulatory compliance using data‑driven insights and robust documentation practices.
About the role
Key Responsibilities
- Develop, implement, and maintain technical standards for product development, ensuring alignment with regulatory requirements and industry best practices.
- Lead cross‑functional teams of subject matter experts to define, review, and approve standard operating procedures and technical guidelines.
- Analyze data and performance metrics to identify gaps, recommend improvements, and track the impact of standards on product quality and efficiency.
- Collaborate with regulatory affairs, quality, and manufacturing to ensure standards support compliance with GxP, ISO, and other relevant frameworks.
- Provide training, mentorship, and guidance to teams on standardization processes and tools.
Requirements
- 10+ years of experience in technical standards development within a regulated life sciences environment.
- Strong knowledge of GxP, ISO, and regulatory compliance frameworks.
- Proven project management skills with a track record of delivering complex initiatives on time and within scope.
- Excellent communication, facilitation, and stakeholder management abilities.
- Advanced analytical skills and proficiency in data visualization tools.
Skills
project managementdata analysis