Associate Director - Clinical Quality

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.

Do you dream of using your solid GCP knowledge, process optimisation skills and quality mind-set in a highly professional and engaged global environment? Can you bring a positive attitude to successfully lead the clinical inspection process while remaining calm under pressure?  
Then you could be a member of our team and serve as an Associate Directors  for Clinical Compliance, Research & Development (R&D) Quality. This role will work out of our Lexington, MA location.  Apply now for this exciting job opportunity! 

Clinical Compliance is one of four sister departments in Clinical Quality (CQ), which is part of R&D Quality in Novo Nordisk. We play a vital role in supporting the drug development process to ensure high quality as well as fit-for-purpose processes. In Novo Nordisk, we have an ambitious drug development program, and we work in a global setting with focus on delivering viable products that make a difference to patients and ultimately benefit society. 
In CQC, we support the development organisation and drive many activities such as:

• being Clinical Quality partners to key projects and line of business, 
• leading the GCP inspections,
• providing GCP support globally
• taking part in due diligence and integration activities when looking at and acquiring new assets, 
• reviewing and approving audit CAPA plans
• performing vendor assessments and trying to impact external clinical requirements and sharing clinical Quality and GCP knowledge to the global organisation. 

We also take active part in cross organizational improvement projects and provide general quality & compliance support to our global organization. We are busy and are on an exciting journey bringing quality on top of the agenda throughout the R&D organization – and maybe you are the one to join us on this journey?
 
 

The Position

This role will provide leadership and guidance to the Global Clinical Organization before, during and after inspections, working with stakeholders across multiple functions.  The Associate Director, CQ, R&D Quality- will also act as the Clinical Quality Line of Business/ key project(s) lead in the Clinical Operations organization, primarily in the East Cost hub, thereby ensuring built-in quality from the start of clinical trials in BGD. Additionally, this role will support the organization in clinical quality and compliance initiatives by participating/leading improvement projects, conduct supplier assessments of clinical vendors, sharing quality and compliance data insights and by focusing and driving process improvement themes. 

Relationships

This position reports to a Manager in CQC, R&D Quality in the Novo Nordisk headquarters in Denmark, with a local "host" manager at local site.
The position does not have any direct or indirect reports.
Interacts with:
Internal Stakeholders – Development management, BGD management, Novo Nordisk Quality, Clinical Development staff worldwide including line management, Development and support functions in all locations (HQ in Denmark, GBS Bangalore in India, Clinical Outsourcing Management, NNI & BGD in North America), CMRs and GCP Audits
External Stakeholders – Health authorities (in particular for inspections), CROs, IEC/IRBs, Data Protection Agencies, Professional networking such as Drug Information Association, relevant Trade Associations and GCP societies globally
 

Essential Functions

• Clinical Quality Partner
  • Quality Partner to Line of Business/key project(s) in the Clinical Operations organization (primarily BGD). Ensure ‘built-in quality from the start of clinical trials in BGD e.g. as ad-hoc member of trial squad, early involvement in vendor selection, protocol development etc.
  • Provide GCP Advice and support to the organization
  • Deploy quality and compliance data insights in support to projects/stakeholders
  • Responsible for leveraging and enhancing GCP, Device and IT understanding
  • Participate in relevant working groups on GCP issues and provide support and advice to the organisation regarding quality issues
• Clinical Inspections
  • Lead sponsor inspections and preapproval site inspections
  • Ensure coordination of all GCP inspections globally
  • Drive the global GCP inspection process from notification through to implementation of commitments to authorities
  • Participating in sponsor inspections with Health Authorities globally, follow-up, trending, and reporting
  • Drive the global cross-functional inspection readiness group to ensure that learnings from GCP inspections are shared, tools developed, and that Novo Nordisk is inspection ready
  • For BGD specifically: Drive local GCP inspection readiness/preparation activities – ensuring SMEs/Skill area representatives are identified and trained, ensuring local process is in place to be able to host sponsor inspections at short notice
• Cross functional tasks within CQC
  • Support the global consistency and compliance of clinical development worldwide with applicable guidelines, regulations, and quality standards through process documentation, information sharing, and guidance
  • Support the planning and conduct of cross-functional trending on quality signals
  • Continuous focus on process improvement and development of areas of expertise
  • Contribute to QMR process – providing data, issue escalation etc.
• Improvement projects as needed
  • LoB project manager and/or project participant in RDQ and Non-RDQ improvement projects
  • Drive improvement actions and proactively identify and facilitate improvement needs within clinical and quality processes
• Clinical Supplier Assessments
  • Conduct clinical supplier assessments

Physical Requirements

The position is located in the Lexington office in BGD. Presence in the office is expected 3 days a week. International and domestic travel should be expected to support inspections and to take part in relevant meetings in Denmark. Up to 30 days a year.

Qualifications

• BSN or B.S. in related scientific field is required; Masters of Science degree is preferred
• 8+ years of experience in clinical research drug development and/or Clinical Quality Assurance; 6 years with a Masters degree may also be considered
• In-depth knowledge of ICH GCP and relevant regulations – and the ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate written and oral findings
• Experience in GCP inspection management; including planning, conduct, inspection CAPA generation and follow-up. The experience must include leading roles such as inspection host & back-room lead
• Experience with clinical quality assurance, clinical trial management/monitoring or GCP Audits
• Organizational and project management skills to communicate effectively to a variety of stakeholders
• Ability to operate autonomously with minimal supervision, interact with stakeholders at all levels with a high level of professionalism in a fast-paced environment, remaining flexible, proactive, resourceful, and efficient
• Excellent written and verbal communication skills, strong negotiation and decision-making skills, and attention to detail are equally important

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.