About this role
About the Role This onsite role supports regulatory compliance and quality operations at Gilead. You will help ensure adherence to regulatory requirements, participate in SOP development, and maintain GMP/GLP programs to deliver high-quality products. The role collaborates across manufacturing and QA teams to enable inspections and audits on an ongoing basis. What You'll Do
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
- Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
- Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis. What We're Looking For
- Understanding of regulatory requirements and quality systems in pharmaceutical/manufacturing environments.
- Experience with SOP development and documentation.
- Knowledge of GMPs and GLPs; ability to maintain compliant programs.
- Ability to review manufacturing, environmental monitoring and quality control data.
- Strong cross-functional collaboration to support inspections and audits. Nice to Have
- (Not explicitly mentioned in the posting) Compensation & Benefits
- (Not mentioned in the posting)