Senior Manager, Quality Systems

Nimbus has an outstanding opportunity for an exceptional Senior Manager, Quality Systems to join our team. The Senior Manager, Quality Systems is responsible for the implementation, management, and maintenance of our Quality Management System (QMS) platform. This role will work closely with QMS stakeholders to maximize system functionality, improve system efficiency and effectiveness, and expand system capabilities to ensure business needs are maintained. You will report to our Senior Director of Quality Operations.

In this role, you will: 

  • Perform configuration, validation and maintenance of QMS platform in alignment with Nimbus’ business requirements, procedures, and regulatory requirements
  • Responsible for Change Management: Coordinate with vendor(s) for product releases, lead internal review of changes, and utilize change control process to implement change requests
  • Oversee the development of system requirements and design or process relevant changes
  • Serve as the primary contact with vendor and resolve incidents/defects within the QMS platform
  • Participate in the development of solutions and manage project/change timelines
  • Provide guidance and support to internal customers in creation and maintenance of functional area procedures and data management
  • Collaborate with functional areas to ensure documents are reviewed and approved
  • Create training materials including web-based training presentations and other supplemental training content. Deliver training content to a diverse audience in an engaging and thought-provoking fashion
  • Monitor quality metrics and prepare monthly reports for GxP related functional areas
  • Ensure that all documentation regarding the QMS is effectively maintained
  • Participate in the strategy, management and integration of systems that impact the QMS, including assessment of vendors and technology
  • Analyze user enhancement requests to deliver solutions focused on establishing and improving business processes to improve efficiency, address process gaps, and enable automation and growth of the organization
  • Provide additional support, access, and management of system users

These qualifications will help this role be successful: 

  • Bachelor’s degree in life science, computer science or health-related field. Advanced degree preferred
  • 5+ years' experience managing Quality Management Systems & administering Computerized Systems within a regulated environment (GCP, GLP, GMP)
  • Experience with system configuration and Computer System Validation (CSV)
  • Knowledge of GxP regulations and approaches to System Life Cycles (SLC) and GAMP
  • Excellent communication and organizational skills required with demonstrated success leading projects and interacting with cross functional teams
  • Ability to navigate, problem-solve, execute, and thrive in a dynamic, fast-paced and evolving environment

A Snapshot of Nimbus 

Our Science  

At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success, we’ve built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.  

Our Culture 

Nimbus is a close-knit company (our employees are Nimbi, if you are curious!) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.  

Our Company 

Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Cambridge, Massachusetts. Learn more about us by going to www.nimbustx.com 

Join Nimbus. We are making a difference and you can too. 

At Nimbus, we believe our diversity of backgrounds and experiences strengthens our community and our ability to design breakthrough medicines. We prioritize creating an inclusive, welcoming culture that promotes our core values and encourages every Nimbi to bring their whole selves to their work. Nimbus is proud to be an equal opportunity employer. We value and celebrate all our employees and recognize that our diversity and inclusion are keys to our success. Nimbus is committed to providing equal opportunity for all employees and applicants without regard to race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.

 

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