Senior Manager, Quality Management Systems

Site Name: Cambridge Binney Street Posted Date: Dec 18 2022 Ready to help shape the future of healthcare? We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021. We continue to modernise, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together. This newly created position provides the opportunity to work directly with Manufacturing, Facilities, Validation and QC staff for continuous improvements of the Quality Management Systems with focus on Document Management. Key responsibilities Be responsible for review and maintenance of Document Control procedures. Responsible for transferring Veeva documents. Be responsible for the organization of cGXP controlled documents in the Document Archive Room and electronic filing system to ensure that records are readily retrievable. Issue production batch records to support manufacturing operations. Provide support for implementation of upgrades or new eQMS platforms. Maintain KPIs for QMS pertaining to Document Control. Work with authors to coach them on generation of ALCOA compliant documents. Maintain audit readiness for their responsible areas. Assist a cross functional team with Deviation, Investigation, CAPA and Change control. Proficiency with MS Office  Why you? Basic Qualifications: A Bachelor’s degree (or higher) in Chemistry, Biology, Engineering, or related field 7+ years of industry experience (3+ years of QA experience) for a biopharma company Experience with vaccines/biologics Experience with Good Documentation Practices and knowledge of regulatory requirements The ability to respond to changing priorities and expectations with a composed demeanor and foster effective cross-functional relationships Excellent communication, writing and presentation skills for interfacing with internal and external organizations Strong collaboration and team skills The ability to think through the process and accurately apply and adapt regulatory standards The ability to understand the QA function in a start-up entity and ability to make decisions on a go/no go criteria The ability to work effectively within a variety of situations and adapt enthusiastically to changes in job demands The drive to pursue tasks with energy, drive, and initiative; even in a fast-paced environment Being comfortable in a results-driven, highly accountable environment where you can make an impact Building productive working relationships across key internal functions The ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure
GSKBinneyStreet
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