Manager, QA Compliance Audits

This is an outst&ing opportunity to join Gilead's evolving progressive Quality Assurance organization.

In this role the successful c&idate will:

- Coordinate & perform audits across both internal/external manufacturing platforms. Identify compliance risks & report findings to appropriate management with recommendations for resolution.
- Work directly with operating entities to ensure completion of corrective actions to address compliance concerns identified during audits
- Demonstrate the ability to incorporate sound Risk Management fundamentals in the establishment & adherence of audits conducted across the commercial manufacturing base.
- Participate in the development, implementation & maintenance of programs/ processes to assist in ensuring compliance with current Good Manufacturing Practices (cGMP) expectations
- Maintain audit schedules to ensure quality oversight of contract manufacturers, contract laboratories & internal functions
- Promote awareness across the commercial & clinical manufacturing platform of current regulatory agency requirements
- Develop & present auditor training modules to Gilead staff & mentor team auditors
- May coordinate & interface with regulatory agencies as required in support of regulatory agency inspections
- Travel is required up to 30%

Manages compliance audits & may manage QA consultants. Leads compliance audits. Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing St&ard Operating Procedures to ensure quality. Maintains Quality Assurance programs, policies, processes, procedures & controls ensuring that performance & quality of products conform to established st&ards & agency guidelines. Provides expertise & guidance in interpreting governmental regulations, agency guidelines, & internal policies to assure compliance. Works directly with operating entities to ensure that inspections, statistical process control analyses & audits are conducted on a continuing basis as specified to enforce requirements & meet specifications. Ensures compliance with current Good Manufacturing Practices (cGMPs) & Good Laboratory Practices (GLPs). Interfaces with contract manufacturers to address documentation & compliance issues. May interface with regulatory agencies as required.