Senior Systems Analyst
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossibleFor Current Gilead Employees and Contractors:
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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.
This position is in the Laboratory Information Systems (LIS) department within the Pharmaceutical Development & Manufacturing (“PDM”) organization. This role will manage validation projects for multiple GMP and Research standalone computerized and server-based laboratory instrument classes and other technologies as required by the laboratories. They will provide direction to contract resources determining and establishing technical and procedural controls for Data Integrity and drafting instrument validation deliverables and will supports initiative to source and assess new technology to improve the cGMP compliance of standalone computerized instrumentation.
- Develops the validation strategy and approach for new standalone computerized instruments.
- Collaborates with QA and Business teams to author the validation plan for instrument validation projects, including the list of required document deliverables needed for supporting projects.
- Reviews/Approves system lifecycle and validation deliverables including IQ/OQ/PQ protocols, traceability matrices, validation summary reports, protocol discrepancies and procedures/work instructions for GMP systems.
- Collaborates in the authoring, review, initial approval, implementation, extension, completion, completion approval and/or closure of change control requests related to relocation/requalification/modification, CAPA, and/or deviations related to GxP-regulated analytical instrument systems.
- Ensures that VAL documentation deliverables are completed in accordance with all applicable procedures.
- Provide VAL assessment and approval for the Periodic Review Program (PRP) of Analytical Operations instruments and equipment. Supports System Audit Trail Review and assists in remediating any findings.
- Responsible for ensuring the validated state of GxP-regulated analytical instrument systems, Cybersecurity controls and Data Integrity of all Standalone Computerized Laboratory Instruments throughout the instrument lifecycle.
- Ensures inspection readiness by supporting regulatory inspection preparation activities and supports regulatory inspections as a subject matter expert for Analytical Instrument Qualification. Participates in and supports any required remediation activities.
- Supports multi-site effort across PDM to harmonize instrument validation processes.
- Assesses current processes and recommends improvements to strengthen compliance requirements and increase efficiency. Escalates issues and provides information/support to management as needed
- Provides support and guidance for contractual validation resources.
- 5+ years of experience in a GMP environment related field and a BS or BA.
- 3+ years of relevant experience and a MS.
- Knowledge of cGMP regulations applicable to analytical instrumentation, laboratory equipment, and data integrity
- In-depth understanding of regulatory guidelines for Computerized System Validation (CSV) and Analytical Instrument Qualification (AIQ)
- Demonstrated experience leading effective teams
- Significant project management training and experience
- Experience in regulatory audits.
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/GileadAbout 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 email@example.com
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