Associate Director, Quality Compliance Corporate QA Audit

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:

• 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%

Knowledge, Experience and Skills:

• 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

Basic Qualifications:

• 10+ years of relevant experience in the pharmaceutical industry and a BS or BA OR 8+ years of relevant experience and a MS.

For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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