Manager - Quality Assurance Good Laboratory Practice

About the Department 
Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by 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. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of 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 and obesity 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 individual will play a key role in providing Good Laboratory Practice (GLP) QA support for the Dicerna TRU Team and non-clinical activities in Novo Nordisk. This role will report to the Head of GLP QA, in R&D Quality in Denmark and must have the ability to work independently on projects and to work under pressure.

Relationships

The Manager – Quality Assurance GLP will report to the Head of GLP QA. This role interacts with Dicerna and Novo Nordisk research teams daily. This role also facilitates interactions with CROs to help with the execution of research workplans. This role does not have direct reports.

Essential Functions

• Ensure quality oversight/compliance verification of GLP requirements at GLP studies
• Conduct GLP assessments of new non-clinical and clinical laboratories (Contract Research Organizations)
• This includes coordinating conference calls, remote and in person meetings, and offsites along with managing associated details and logistics
• Monitor and review computerized systems documentation used in Novo Nordisk GLP-regulated laboratories conducting GLP and GCP activities
• Partner with Study Management Team (SMT) members and other internal stakeholders to manage clinical/non-clinical vendor and/or clinical site oversight
• Provide GLP guidance to internal stakeholders or Study Management Teams, as applicable
• Takes an active role in creating a positive first impression of Dicerna TRU for all employees, vendors and visitors, possesses a strong customer service mentality
• Responsible for ensuring that high quality standards and efficient processes are followed
• Participate in ad-hoc tasks and projects in the GLP QA department and globally across Novo Nordisk & with external collaboration partners
• Participate in inspections by regulatory authorities and play a key role
• Serve as a point of contact for Dicerna TRU research teams to facilitate communication and for coordinating research workplans and timelines
• Promote compliance and quality throughout the company and represent the Quality Department at internal meetings and events
• Build, develop and maintain working relationships with internal and external partners
• Participate as GLP QA expert on GLP studies at facility audits

Physical Requirements

10-20% overnight travel required.

Qualifications

• MS degree in a relevant scientific discipline preferred (Medical Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Science, etc.)
  • Minimum of a Bachelor's Degree with 10+ Years of experience required.  
• Advanced degree with 8+ years of experience.  
• 5+ years of experience within GLP Quality Assurance.  
• Demonstrates commitment and consistent achievement of goals through constructive collaboration with colleagues.
• Excels at navigating and thriving in complex research environments and organizations.
• Possesses a highly developed business mindset.
• Ability to work independently and collaboratively.
• Microsoft Office skills, time management skills, internet research abilities, and technical skills.
• Proven customer service skills, internal, and external customers.

Additional Preferred Qualifications 

• Forward thinking, ability to foresee and intercept conflicts before they arise
• Problem solving skills
• Dynamic, extensive calendar management with travel scheduling experience
• Strong written and verbal communication skills
• Excellent organizational skills and attention to detail
• Contribute to organizational culture by helping to facilitate corporate values, spirit; making Dicerna a great place to work, respected for the quality of its people and products
• Serves as a role model by displaying initiative and enthusiasm.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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.