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Gilead Sciences, Inc. Quality Product Team Lead (Associate Director) 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:

Quality Product Team Lead (Associate Director)

The primary responsibilities of this role, Quality Product Team Lead Biologics and New Modalities, are to:

  • Responsible for end-to-end quality oversight for assigned products within the company’s biotechnology product portfolio (e.g. monoclonal antibodies, fusion proteins, conjugated monoclonal antibodies).

  • Holds key expert quality and technical knowledge for assigned products within the biotechnology product portfolio.

  • Represents Biologics Quality functions to enable informed decision making for assigned products.

  • Supports adherence of product development, manufacturing and logistics operations with applicable regulatory agencies

Essential Duties and Job Functions:

  • Direct efficient expert network with site Quality and business functions;

  • Product stored for several for development and clinical products

  • Represent Biologics Quality on various Product Teams;

  • Continuously develop key expert knowledge for products;

  • Share key knowledge for business decisions;

  • Partner as product key expert with e.g., Regulatory, Medical Affairs, Supply Chain Management, PROC, Marketing, Commercial, Affiliates/HUB operations, etc., for Biotech Products;

  • Partner as Biotech product key expert within PDM Quality to enable informed decisions related to e.g., issue management, change management;

  • Direct and monitor Corrective and Preventive Actions (CAPA) resulting from e.g., issue management, change management globally for respective products;

  • Monitor Quality along supply chain for respective products (internally/externally) by;

  • Set definitions of appropriate product quality standards that ensure compliance of products with applicable regulatory standards and customer expectations;

  • Ensure compliance by monitoring Quality Management Reviews (QMR), Product Quality Reviews (PQR) and Annual Quality Review (AQR) for respective products;

  • Conduct quarterly global product complaint reviews;

  • Conduct bi-annual comprehensive quality management review to ensure compliance of respective products;

  • Conduct quality risk management for respective product portfolio.

This role can be based out of our Oceanside, CA, Foster City, CA or Morris Plains, NJ site.

Knowledge, Experience and Skills:

  • Product expertise or an equivalent combination of education and experience;

  • Quality Assurance experience and knowledge of biotechnology processing and testing;

  • Demonstrated experience leading cross-functional teams and influencing through indirect leadership to build collaboration and drive resolution;

  • An in-depth knowledge of pharmaceutical analytical technologies, including sterile manufacturing and packaging, software development and distribution including all governmental and agency regulations;

  • Expertise and knowledge in Good Manufacturing Practices (GMP) engineering facilities and equipment design concepts in order to review engineering projects for compliance impact;

  • Broad cGMP experience and knowledge, Quality Assurance (QA)/Quality Control (QC) and regulatory compliance (U.S. and other international agencies);

  • Business process management and stakeholder management skills;

  • A working knowledge of statistics and computerization (electronic documentation) of QA Data;

  • Ability to communicate effectively with people at all levels in the organization, from other departments and divisions, as well as regulatory agencies;

  • Navigate matrix organizations and support multiple business processes;

  • Strong leadership and interpersonal skills, excellent communication, presentation and influencing skills, change management experience and skills, very good partnering and networking skills, ability to build on diversity and inclusion.

Basic Qualifications:

  • 10+years of relevant experience and a Bachelor’s degree in science or related fields. OR 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.

  • Knowledge and experience in quality assurance in a highly regulated manufacturing environment.

  • Prior people management experience.

Preferred Qualifications:

  • Experience in cell and gene-based therapies a plus

  • Experience in Biotech

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.

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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.

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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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