Quality Specialist

About the Department                                                                                                                                    

Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.

The team is comprised of collaborative, diverse and passionate people who have a true sense of pride in their work and are committed to helping others grow and develop their careers. You’ll also have a platform to engage with key stakeholders on a global scale throughout the entire pipeline process. And while changing the future of diabetes, obesity and MASH treatment is no easy task, we also recognize the importance of an enjoyable workplace, which is why we’ve cultivated a culture of fun, ingenuity and innovation. And our competitive compensation package and support of a healthy work-life balance all add to a best-in-class employee experience. We are changing lives for a living. Are you ready to make a difference?

 

The Position

This position actively supports Veeva system which is used in collaboration with QMS related to Document Management, Records Management, Change Control and Training Documentation/support processes. Support and implement process improvement opportunities for the Veeva system. Support all Quality Management Systems (QMS) customer requests. Train and support customers in Quality Systems owned by QMS department.  Coordinate and support business needs during audits and inspections.

 

Relationships

This job reports to a Director in QMS & Training. This position interacts with all departments at the Watertown site who utilize the Veeva system. This position also interacts with the Global Novo Nordisk QMS people in Denmark. Independent contributor, no direct reports.

 

Essential Functions

• Veeva Admin:
  • Process documents in Quality Vaults of QualityDocs
  • Identify areas for process improvement within the workflows; listen to feedback from customers
  • Implement improvements or systems identified in QMS that support department or customer needs
  • Manage site document archival process for electronic and paper records
• Training:
  • Train users on the functionality and process in QualityDocs in Veeva
  • Assign training within Veeva to all required individuals
  • Continually improve the training assignments
  • Run metrics on training
• Ensure site compliance with regulations, ISO standards and Corporate/local procedures
• Review and author QMS documentation (e.g. SOPs, validation documents), as required

• Other responsibilities, as assigned

 

Physical Requirements

0-10% overnight travel required. Moves equipment and/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to work with a computer and keyboard.

 

Qualifications

• Education Level: Minimum BA/BS in a scientific discipline with 3+ years of relevant experience required. Advanced degree may be substituted for 2 years experience. An Advanced degree may be substituted for 2 years experience. 
• Experience Level:
  • 2+ years in electronic QMS; Veeva preferred
  • 2+ years’ experience with deviations, CAPA and Change Control

• Knowledge in the following systems:
  • Document Management, Change Control, Deviations, Audits & Inspections, Records Management processes / databases
  • Strong communication skills (verbal & written) and the ability to coach and train adult learners
  • Strong attention to details and excellent proof-reading ability
  • Strong computer skills necessary to learn and train others regarding Veeva system associated with QMS responsibilities
  • Knowledge of pharmaceutical manufacturing processes
  • Willingness to improve processes and business
  • Ability to work with cross functional teams
• Agility:
  • Quickly flexes to changes in roles and responsibilities, environments and business needs with grace and ease
  • Experience with Microsoft WORD, Excel, Visio
  • Customer/Results Dri