The Associate Director - Corporate QA Audit, will report to the Sr. Director of Corporate QA Audit Program. This key position will oversee the management for Gilead's Corporate Audit Program for Gilead affiliates and third-party logistics. This position will lead numerous program management activities and processes to support the effectiveness of the global audit program. Establish consistent audit standards and performance metrics, as well as establish a harmonized supplier program management across Gilead.Roles/Responsibilities:
Knowledge, Experience and Skills:
- Manage all aspects of the audit lifecycle: scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CAPA, and closing
- Incorporate sound risk management principles for the establishment of the annual audit schedule.
- Develop and maintain updates to annual global audit schedule
- Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.
- Perform internal audits for Gilead affiliates and third-party logistics
- Work directly with auditees to ensure completion of correct CAPA to address compliance concerns identified during audits
- Identify compliance risks and escalate issues to appropriate levels of management for resolution
- Develop and report trends based on internal / external regulatory observations to better focus the scope
- of audits
- Manage contractors/consultants that support the audit program and ensure that they have the required skills, training and procedural qualification requirements
- Drive consistency with audit report observation classification, status and overall risk
- Participate in the development, implementation and maintenance of procedures and templates to assist the evaluation and audit process
- Assist with the development and manage the auditor qualification, training requirements and develop effective auditing tools
- Create, publish, and maintain metrics that measure the health and effectiveness of the audit program
- Identify and drive program improvements.
- Other responsibilities as required
- Travel may be required - up to 50%
- Demonstrates a thorough knowledge and application of global compliance requirements including 21 CFR Parts 11, 210, 211, 820; EudraLex Volume 4 and applicable annexes; EU Good Distribution Practices for Medicinal Products and Health Canada GMPs; as well as ICH and ISO standards
- In-depth knowledge of audit process and risk-based principles
- Excellent program management, organizational skills, ability to work independently, under minimal direction
- Effective communication skills within a matrix management environment (verbal, written and presentation)
- Possesses a strong quality, compliance and continuous improvement mindset
- Collaborative team player with the ability to work in a Matrix organization
- Technology Savvy in the current workplace tools/systems including Microsoft Office and TrackWise
- 10+ years of relevant experience in the pharmaceutical industry and a BS or BA OR 8+ years of relevant experience and a MS.
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