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R&D Info Systems Associate Director, R & D Information Systems - LIMS
This position is in the Laboratory Information Systems (LIS) department within the Pharmaceutical Development & Manufacturing (“PDM”) organization.The associate director is responsible for Laboratory Information Management System (LIMS) data management which encompasses elements of data quality, integrity, accuracy, and completeness. This includes leading the critical processes and technical creation and updates of tests and specifications used in test result evaluation to determine whether a test meets acceptance criteria, as well as its use in trending, alert limits, action limits and reporting on Certificate of Analysis.
- Lead LIMS data management teams at multiple sites to ensure that master and reference data is managed in an accurate, complete and timely manner. Data include product specifications and test methods in LIMS, test methods in a Lab Execution System and templates in Empower chromatography data acquisition. These are GMP computerized systems used in analytical development, quality control and commercial manufacturing.
- Life cycle management of specifications (Clinical to Commercial) used in the testing of: drug products, active pharmaceutical ingredients, raw materials, reference standards, authentic substances and toxicology samples. Optimize operations to reduce the cycle-time of data management to support rapid product development timelines, promote good manufacturing practices and operational excellence.
- Work closely with specification stakeholders to drive process harmonization and data standardization. Manage the activities assigned to all staff (full-time and contracted) to ensure the timely delivery, quality and compliance of completed work.
- Work closely with LIMS administration, validation, and support teams as appropriate to achieve the most effective overall solution involving master data updates.
- Work with various groups within Gilead including analytical operations, quality assurance, Regulatory Sciences-CMC, project managers and vendors to develop budgets and monitor expenditures.
- Responsible for effectiveness checks, monitoring, and proactive reporting of risks and issues to management; as well as determining options and solutions and executing upon approved solutions
- Create and update procedures, work instructions, business process catalogs, business process maps, business process narratives, data flow diagrams to clearly describe operations
- Present and describe functions and operations clearly and concisely to regulatory inspectors, demonstrating activities are in a state of control, with understanding of the technical and procedural controls used
Knowledge, Experience and Skills:
- A Bachelor's Degree with a minimum of ten (10) years of experience, OR a Master's Degree with a minimum of eight (8) years of experience, OR a PhD with a minimum of four (4) years of experience.
- Highly experienced in domain areas such as drug development, stability protocols, analytical chemistry, information technology, LIMS, data management, cyber security, data protection, cGMP and pharmaceutical regulatory compliance. Experience in managing a technical support organization.
- Possess strong abilities to manage, develop and improve people, processes, operations and technology. Drive for excellence, develop team and manage for success. Provide solutions to highly complex problems and apply a high degree of ingenuity, creativity and innovation.
- Understanding of the regulatory requirements in the area of pharmaceutical development and manufacturing, including 21 CFR Part 11, 21 CFR Part 210, 211, 21 CFR Part 820, and 21 CFR Part 58. In addition, knowledge of regulatory guidance documents issued by US FDA, Pharmacopeia (USP, EP), and EMEA regulatory agencies
- Experience with Microsoft Office tools, specifically Outlook, Word, Excel, PowerPoint and Visio.
- Ability to work in a fast-paced environment.
- Exceptional interpersonal skills, including teamwork, coordination, facilitation, and negotiation.
- Strong leadership, communication and presentation skills.
- Excellent analytical, problem-solving and technical skills.
- Detailed oriented, systematic and rapid learner.
- Excellent planning and organizational skills.
- Exceptional written and verbal communication skills.
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
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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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For Current Gilead Employees and
Please log onto your Internal Career Site to apply for this job.