Senior Patient Safety and GxP Document Oversight Manager

Senior Patient Safety and GxP Document Oversight Manager

Facility : Reg Affairs & Safety Pharmacovigilance

Location : Plainsboro, NJ, US

About the Department

The 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 Position

We 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.

Relationship

This 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 Functions

• GxP Documentation Management
• Develop and implement comprehensive documentation management systems and processes for all GxP documentation, ensuring adherence to regulatory standards.
• Maintain an up-to-date inventory of GxP documents, including Standard Operating Procedures (SOPs), Work Instructions (WIs), and other essential compliance documentation.
• Coordinate document reviews, approvals, and revisions, ensuring timely updates and compliance with internal and external requirements.
• Monitor and track the lifecycle of GxP documents to ensure they are effectively managed, properly archived, and readily accessible when needed.
• Key Area #1 Process Oversight and Compliance
• Establish and enforce GxP documentation standards and best practices across the organization, ensuring consistency and compliance with FDA, EMA, and other regulatory guidelines.
• Conduct regular audits of GxP documentation to verify compliance and identify areas for improvement or corrective actions.
• Collaborate with cross-functional teams to ensure that GxP documentation practices are integrated into operational processes and compliant with industry standards.
• Serve as a subject matter expert on GxP documentation requirements, providing guidance and support to staff across departments.
• Key Area #2 Training and Education
• Develop and implement training programs on GxP documentation best practices and regulatory requirements for employees at all levels.
• Facilitate workshops and seminars to enhance staff awareness of GxP documentation standards and the importance of compliance.
• Evaluate training effectiveness and make adjustments to programs as needed to improve overall understanding and adherence.
• Key Area #3 Performance Monitoring and Reporting
• Define key performance indicators (KPIs) for GxP documentation management and conduct regular assessments to track performance against established metrics.
• Prepare and present regular reports on documentation compliance, audit results, and improvement initiatives to senior management.
• Lead continuous improvement initiatives related to GxP documentation processes, leveraging data-driven insights to enhance efficiency and effectiveness.

Physical Requirements

Approximately 20% overnight travel.

Qualifications

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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.