Senior Patient Safety and GxP Document Oversight Manager

Business Process Oversight Manager

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

Process Oversight and Compliance

Training and Education

Performance Monitoring and Reporting

Qualifications

Bachelor's degree in a relevant field (Life Sciences, Quality Assurance, Regulatory Affairs, etc.); advanced degree preferred

7+ years of experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotechnology industry

Strong knowledge of GxP regulations, documentation standards, and industry best practices

Proven experience in auditing, process improvement, and implementing documentation management systems

Excellent organizational, analytical, and problem-solving skills, with attention to detail

Strong interpersonal and communication skills, capable of collaborating effectively with cross-functional teams

Proficiency 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.