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Gilead Sciences, Inc. QA Specialist III in Morris Plains, New Jersey

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Role and Responsibilities:

Gilead Sciences is looking for a QA Specialist III to join our External QA Team. This position will provide QA oversight to PDM Biologics Contract Manufacturing Organizations in support of Drug Product manufacturing activities across clinical or commercial programs for external manufacturing operations.

This position can be based out of the Foster City, CA, Oceanside, CA, or Morris Plains, NJ locations.

Essential Duties and Job Functions:

  • Performs Quality Assurance activities to ensure compliance with applicable quality objectives and applicable US and International regulatory requirements.

  • Participates in writing or suggesting changes to controlled documents (e.g., SOPs, specifications, etc.) as needed to ensure defined quality objectives are met.

  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).

  • Provide Quality oversight to biologics Contract Manufacturing Organization (CMO) operations including but not limited to review/approval of CMOs site related deviations/investigations, CAPAs, Change Controls, and inspection management.

  • Reviews manufacturing, environmental monitoring and quality data for in-process and finished products.

  • Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications.

  • Attends and/or communicates events and outcome of Issue Escalation meetings/decisions site related.

  • Provides support in the writing of annual product reviews and the development of CMO training programs regarding all aspects of producing quality products.

  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.

  • Interfaces with Research and Development during new product start-ups and establishes key checkpoints for new products and processes.

  • May assist or lead compliance audits as required. May interface with regulatory agencies as required.

  • Interacts with CMOs to address investigations and quality issues requirements.

  • Authors concise quality investigation reports with appropriate corrective action and preventive actions (CAPA).

  • Varying levels of knowledge in laboratory controls and method validation per FDA/EU/ICH/USP guidelines.

  • Acts as an Analytical QA subject matter expert in support of regulatory inspections and internal audits.

  • Demonstrates ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.

Knowledge, Experience and Skills:

  • Proficient in GMPs and/or GLPs.

  • Proficient in application of Quality Management Systems across the different clinical phases.

  • Demonstrates ability to effectively manage multiple projects/priorities.

  • Excellent written and verbal communication skills required, including Responsible Business Communication.

  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.

Basic Qualifications:

  • 6+ years of relevant experience in a GMP environment related field and a BS OR 4+ years of relevant experience and a MS.

  • Prior experience in pharmaceutical industry is beneficial.

  • Preferred experience working with CMOs.

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

About Gilead:

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.

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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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.

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