Quality Compliance Lead - 100% Remote (Life Science Exp) W2 only - 3463

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timePosted 8 days ago location United States salarySalary undisclosed
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Job Description

IT Quality Compliance Lead (Life Sciences) ndash 100 Remote ndash W2 Only - 3463 BB3463 Bridgewater, NJ 08807 6+ Months Quality Operations Partner ndash Research Early Development Job Summary The selected candidate for this position will be temporarily acting as the Quality Operations Partner, Research Early Development, a member of the Digital (IT) Quality Operations team supporting the RD and Medical IT application and project teams. In this capacity shehe provides expertise and guidance on Quality Compliance (QC) in a (primarily) GxP-regulated and very dynamic environment under the supervision of the Head of Digital (IT) Quality Operations RD and Medical. Shehe is the point of contact for IT Service Lines supporting the Research early Development, Translational Medicine and Global Clinical Immunology Development business areas and collaborates closely with IT Service Line Leaders and Service Owners to identify and address QC requirements related to their application and project portfolios. In addition, key responsibilities include providing Computerized System Validation expertise, guidance and oversight for regulated systems, supporting audits inspections, providing awareness and training to Quality, Compliance and software development lifecycle topics. The position requires detailed knowledge of and experience with regulations and software validation requirements in the PharmaceuticalBiotechnology industries and the ability to successfully collaborate in multi-cultural and multi-disciplinary teams across locations and time zones. Knowledge and Skills bull Broad understanding of information technology solutions in pharmaceutical RD, esp. in earlypre-clinical development bull In-depth knowledge and several years of experience with Quality Management, GxP regulations and Computerized System Validation (CSV) as they pertain to this business area as well as awareness of other regulations (such as data privacy) bull Practical experience with using agile methodologies as well as implementing cloud-based solutions in a regulated environment is highly desirable bull Effective oral and written communication (in English) with various stakeholders, including technical teams as well as RD IT Management bull Ability to build strong customer relationships, effectively contribute to and influence decision making, and resolve conflicts with stakeholders with tact and diplomacy bull Work and communicate effectively as a member of global, cross-functional, multi-national project teams or work groups bull Work autonomously and execute activities of varying complexity with limited supervision bull Coordinate with managed service provider for Quality Services as required in the scope of projects and applications Major Duties and Responsibilities Supporting Relationship Management with Digital (IT) RD Service Lines bull Be the point of contact for and partner with the Service Lines to promote quality and compliance throughout the system life cycle bull Plan for and provide appropriate Quality Compliance support for the project and application portfolios of the Service Lines in collaboration with the Head of Digital (IT) Quality Operations RD and Medical. bull Provide awareness and training on QC topics, including Quality Management System, CS validation and lifecycle methodology (as required in collaboration with other Quality Operations team members) bull Coordinate and collaborate with transversal Quality Operations teams to provide services such as Audit and Inspection support, CAPA Management, Third Party Audit and Risk Management Computerized Systems (CS) Validation, Change and Risk Management bull Advise and guide project and application teams on and oversee validation activities in collaboration with Business Quality and our managed service provider for Quality Services bull Ensure compliance of programsprojects and applications with applicable regulatory and internal requirements by leading risk assessments, validation and testing strategy, planning and closeout ndash in collaboration with our managed service provider for Quality Services bull Work jointly with IT Quality Risk Managers and application teams to ensure compliance risks related to applications are properly detected, documented and addressed. Audits and Inspections bull Collaborate with AuditInspection readiness team members, Business System owners, Business Quality and Service Line representatives to prepare for regulatory inspections and internal audits, respond to questions and address findings through correctivepreventive action plans to improve compliance and effectiveness of the Quality Management System