Senior Manager - cGMP LIMS Administrator
Senior Manager - cGMP LIMS Administrator
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. Gileads 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 companys five core values. Thats 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 #CreatingPossible
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:
The Senior Manager, R&D Information Systems will be responsible for supporting and maintaining the Clinical and Commercial LabWare LIMS system in accordance with GMP regulations and Gilead policies.
Essential Duties and Job Functions:
- Provide expertise and guidance to the Business and other laboratory system groups in the planning, use and adoption of LabWare LIMS system
- Review and Assessment of risk as well as work with QA to ensure accuracy and timeliness for change management
- Transform business requirements into detailed designs that can be implemented.
- Manage, direct, and review design and deliverables of developers throughout the software development phase
- Perform functional validation activities including IQ/OQ/PQ and master document review, executing and reviewing deployments of all system changes
- Work with LIS and Gilead's business stakeholders at all seven sites to communicate pertinent system information and prioritize requests
- Manage on-time completion of quality records (PR's, CAPA's, deviations)
- Manage low risk change process
- Ensure the content of all documentation and training material is technically correct
- Participate/lead internal team meetings as well as with the business
- Identify and implement process improvements for the team
- Coordinate with LIMS Support and LIMS Administration to set priorities for problem resolution
- Provide level 3 production support as needed
- Help to defend LIMS during internal and regulatory GMP system audits
Knowledge, Experience and Skills:
- Bachelors of Science Degree in Computer Science, Information Systems, Chemistry or other related field
- Prefer at least 6 years of laboratory informatics relevant work experience
- At least 3 years managing or developing LabWare LIMS work experience
- Strong SQL skills required, preferably with Oracle
- LabWare LIMS Administration certified preferred
- Experience in all phases of software development life cycle introducing medium-to-large-scale change in a corporate environment
- Experience managing, directing and coordinating the work of subordinate staff preferred
- Strong laboratory informatics software and application (specifically LIMS) knowledge and of relevant technologies/architectures
- Experience in Global LabWare LIMS rollouts, especially LW7+ is preferred
- Experience with commercial biologics, Antibody-Drug Conjugates and support for BLAs is preferred
- Strong analytical, problem-solving and conceptual skills
- Good verbal and written communication skills
- Background in Pharmaceutical industry preferred
- Solid knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, and other regulatory requirements preferred
- 8+ Years with BS, BA and or relevant experience
- 6+ Years with MS, MBA
- 2+ Years with PhD
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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' 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.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Senior-Manager--R-D-Information-Systems_R0020121-1
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