Senior Manager, Corporate Quality Audits

- Coordinate & perform audits of internal sites & distributors to ensure that quality systems are robust & in compliance with regulatory requirements
- Participate in the annual risk evaluation of distributors to determine audit plan
- Execute audits in accordance with established audit programs
- Ensure follow up & completion of open audit events, especially those arising from regulatory agencies inspections, internal audits & distributor audits.
- Provide input to quality management review metrics & communicate areas which need additional controls &/or improvement
- Assist in the evaluation of quality concerns, trends & escalation of compliance risks
- Assist with the configuration, testing & implementation of the enterprise system for audit management
- Be part of the Corporate Quality team to build overall corporate quality systems across the organization
- Work with Quality organizations to ensure that quality systems are robust & in compliance with regulatory requirements
- Be part of the Corporate Quality team to build overall corporate quality systems across the organization by developing corporate procedures, as warranted.
- Travel is required

Reporting to the Director of Corporate Quality Audits, the Sr. Manager will participate in the implementation of the Corporate Quality Audit program. This person will participate in the identification, development, & continual improvement of quality systems across GMP/GDP regulated areas of the company & also be responsible for providing data on key compliance indicators, escalating quality/compliance concerns & supporting the efforts of Gilead Quality organizations in hosting regulatory inspections, as necessary.