Specialist III, QA Compliance [United States]

 

For Current Gilead Employees and Contractors:

Please log onto your

Internal Career Site

to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

$ads={1}

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

*Experience with Biologics Products and Veeva QMS is a plus*

Specific Main Job Responsibilities:

• Manage all aspects of the audit lifecycle including scheduling, planning, drafting and issuing audit agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA and closing.
• Manage the lifecycle of external supplier audit records in systems, ensure timely update and closure of audit records per procedural requirements.
• Review and approve audit reports.
• Work with internal and external stakeholders in various supporting activities for audits.
• Coordinate various audit supporting activities with third party audit service providers.
• Manage and work with manager to triage new audit requests and due diligence assessments.
• Manage and process various activities in the Product Lifecycle Management system.
• Work with manager in developing and reporting trends based on internal and external regulatory observations to better focus the scope of supplier audits.
• 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, as needed.
• Work directly with suppliers to ensure completion of correct CA/PA(s) to address compliance concerns identified during audits.
• Work with manager on incorporating sound risk management principles for the establishment of the annual audit schedule.
• Develop and maintain updates to the annual global audit schedule.
• Identify compliance risks and escalate issues to appropriate levels of management for resolution. Present escalations in stakeholder and management meetings.
• Create, publish and maintain metrics that measure the health and effectiveness of the audit program.
• Work with manager to identify and drive non-CXO audit program improvements.
• Assist in development and continuous improvement of effective auditing tools and training aids.
• Support in training contractors/consultants who support the audit program.
• Participate in audits and support projects
• Create and provide audit attestations as needed.
• Ensure that the information for supplier is accurate in the system to drive accuracy of the approved supplier list.
• Support risk assessments and supplier change management processes as required.
• Support regulatory inspection and mock inspection as required.
• Participate in the development, implementation and maintenance of procedures and templates to assist in the evaluation and auditing of suppliers.

Demonstrated Knowledge and Skills:

• Solid understanding of the current pharmaceutical industry and applicable regulations and standards including 21 CFR, EU GMP, Health Canada, ICH, WHO, ISO etc.
• Good working knowledge of Quality Management System (QMS) fundamentals, processes, effects, and the relationship between the QMS and products.
• Solid working knowledge of Electronic Document Management Systems (EDMS).
• Good understanding of system administration.
• Proficiency in Microsoft Office applications.
• Good verbal, written, and interpersonal communication skills.
• Good organizational skills and ability to work in a fast paced environment with tight timelines.
• Good attention to detail, and ability to consistently meet standards required in Compliance.
• Ability to work both independently and in a team environment collaboratively.
• Audit and investigation skills, and report writing skills
• Critical thinking skills.

Basic Qualifications:

• 6+ years of relevant experience in the pharmaceutical industry and GMP environment, and a BS or BA degree

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community:

https://gilead.avature.net/Gilead

The salary range for this position is: $112,030.00 - $144,980.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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.

For more information about equal employment opportunity protections, please view the

'Know Your Rights'

poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT

YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your

Internal Career Site

to apply for this job.

$ads={2}

 

.