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Senior Patient Safety and GxP Document Oversight Manager
2 weeks ago
About the DepartmentThe Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?The PositionWe are seeking a highly organized and detail-oriented Business Process Oversight Manager to oversee all aspects of Good Practice (GxP) documentation management within our organization. This role will be responsible for ensuring that all GxP-related documentation is accurately maintained, routinely reviewed, and compliant with regulatory requirements. The ideal candidate will have a strong background in documentation management, process oversight, and regulatory compliance within the pharmaceutical or biotechnology industry.RelationshipThis job reports to the Senior Director of the GxP Compliance & Technical Operations or the Director, GxP Compliance, Patient Safety, & Vendor Oversight. This job will interact with Patient Safety, Quality, Vendor and Contract Management, IT, Finance, Contract/Supplier of Customer Engagement Programs, and other CMR Functional areas. This job will lead a team of Patient Safety training and vendor training oversight managers and or technical writers and interact with internal and external stakeholders.Essential FunctionsGxP Documentation ManagementDevelop and implement comprehensive documentation management systems and processes for all GxP documentation, ensuring adherence to regulatory standardsMaintain an up-to-date inventory of GxP documents, including Standard Operating Procedures (SOPs), Work Instructions (WIs), and other essential compliance documentationCoordinate document reviews, approvals, and revisions, ensuring timely updates and compliance with internal and external requirementsMonitor and track the lifecycle of GxP documents to ensure they are effectively managed, properly archived, and readily accessible when neededKey Area #1 Process Oversight and ComplianceEstablish and enforce GxP documentation standards and best practices across the organization, ensuring consistency and compliance with FDA, EMA, and other regulatory guidelinesConduct regular audits of GxP documentation to verify compliance and identify areas for improvement or corrective actionsCollaborate with cross-functional teams to ensure that GxP documentation practices are integrated into operational processes and compliant with industry standardsServe as a subject matter expert on GxP documentation requirements, providing guidance and support to staff across departmentsKey Area #2 Training and EducationDevelop and implement training programs on GxP documentation best practices and regulatory requirements for employees at all levelsFacilitate workshops and seminars to enhance staff awareness of GxP documentation standards and the importance of complianceEvaluate training effectiveness and make adjustments to programs as needed to improve overall understanding and adherenceKey Area #3 Performance Monitoring and ReportingDefine key performance indicators (KPIs) for GxP documentation management and conduct regular assessments to track performance against established metricsPrepare and present regular reports on documentation compliance, audit results, and improvement initiatives to senior managementLead continuous improvement initiatives related to GxP documentation processes, leveraging data-driven insights to enhance efficiency and effectivenessPhysical RequirementsApproximately 20% overnight travel.QualificationsBachelor's degree in a relevant field (Life Sciences, Quality Assurance, Regulatory Affairs, etc.); advanced degree preferred7+ years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotechnology industryStrong knowledge of GxP regulations, documentation standards, and industry best practicesProven experience in auditing, process improvement, and implementing documentation management systemsExcellent organizational, analytical, and problem-solving skills, with attention to detailStrong interpersonal and communication skills, capable of collaborating effectively with cross-functional teamsProficiency in documentation management software and Microsoft Office Suite (Word, Excel, PowerPoint)Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.The base compensation range for this position is $116,810 to 216,100. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance.Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.We’re not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. Print job Send to e-mail
