Business Systems Analyst Princ Job in Framingham, Massachusetts US
Business Systems Analyst Princ
Description
Description
One of the world's leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since its founding in 1981, the company has introduced breakthrough treatments that have provided new hope for patients. The company's areas of focus are rare genetic diseases, multiple sclerosis, cardiovascular disease, and endocrinology. Genzyme is a Sanofi company. Genzyme's press releases and other company information are available at www.genzyme.com.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Job Responsibilities/Department description:
As a Business Systems Analyst Principal you will be an integral member of the Product Data Management System (PDMS) Group. The PDMS is an enterprise-wide (globally deployed) system designed to manage product data and analytical results of manufacturing samples, through the different stages in QC, and final release by QA. The PDMS is comprised of an integrated set of tools (COTS LIMS, ELN, CDS and custom Product Release Module) which automate the product testing and release process, encompassing the development, quality and manufacturing disciplines. PDMS functionality includes integration with other development, quality, regulatory and manufacturing applications such as ERP, QMS, MES and other corporate product information management systems.
The systems PDMS supports facilitate QC testing as well as the QA product release process, including sample chain of custody, automated specification updates, scheduled and automated notifications, sample forecasting and scheduling, instrument data capture and processing, COA generation and report writing, and scheduling. Samples managed include environmental monitoring and utility samples, product and process samples, stability samples, and new product samples being tested in QC and Development laboratories.
Position Summary
Develop and enhance system functionality while working closely with the business to identify solutions to current and future business needs. Work with business sponsors to develop business requirements for new or changed PDMS products and services. Ensure that the vision as defined by the business sponsors is appropriately implemented by working closely with the technology team. Ensure consistency and compatibility across the multiple projects and systems where appropriate.
• Demonstrate understanding of system life cycles, system interfaces and enterprise systems.
• Strong Quality background in Quality Control or Quality Assurance
• Demonstrate strong understanding of industry standards, to align customer requirements with standards during development process, and provide business process recommendations.
• Liaison between PDMS management, PDMS internal departments, user population and business stake holders.
• Gather and document requirements in partnership with Users and Stake Holders.
• Create and develop, and obtain approval of project deliverables. This includes Business Cases, Scope Context Diagrams, Requirements Gathering Plan, Risk Assessment, User Requirements Specification (URS), Trace Matrix, and Use Cases when applicable.
• Facilitate requirements changes between customers and administrators.
• Implements change control procedures for configuration, enhancements and customization to the PDMS.
• Conduct testing and debug modifications and be involved in system validation testing.
• May conduct classroom and WebEx training for users.
Qualifications
Basic Qualifications:5 - 8 years experience with FDA regulations and industry guidance documents, including cGxP, 21 CFR Part 11.
• Bachelor's degree and 9 or more years.
• Master's degree and 7 or more years.
• 5 - 8 years documenting and supporting electronic systems or equivalent experience.
• Minimum of 3 years experience with FDA regulations and industry guidance documents, including cGxP, 21 CFR Part 11.
• System analysis and design skills.
• Must be able to travel, domestic and international, approximately 10% of the time.
Preferred Qualifications:• Administrator or software support, specifically with a LIMS
• Applied software system analysis and design experience.
• Experience with software development life cycle (SDLC) and validation methodologies.
• Strong Requirement Gathering skills
