Senior Director - Compliance

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. Are you ready to make a difference?

 

The Position

This senior quality role will have overall responsibility for compliance topics within the acquisition sites (Cham, Anagni, Brussels, Bloomington) and will support improvements to the site's compliance profiles, including support during regulatory inspections, ensure sharing of findings between sites and harmonizing with Novo Nordisk approaches. This role will sit on the AMIQA Quality Leadership team.

 

Relationships

Reports to the CVP of AMI QA.

Key stakeholders: CVP AMIQA Quality, CVP Complaints, Inspections and Audit, Site Quality Heads, Quality and Site Integration Leads and Key management from sites.

 

To accomplish goals/objectives this job interacts on a regular basis with: Senior management of external/global CDMO customers, CVPs of the Italian, Belgium and US-based acquisition sites, CVP of Quality Excellence and Innovation and Site quality and compliance team members responsible for audits, compliance improvements, procedures and processes.

 

Essential Functions

• Ensure consistent compliance for Acquisition Sites:
  • Interact with sites to understand areas of compliance risk
  • Provide expertise in closing gaps
  • Interface with site leadership and corporate leadership to support funding and prioritization of efforts
  • Monitor changes in regulations and work to proactively install at the sites
  • Establish site collaboration forums to drive harmonization
• Work with internal and external experts to conduct a compliance gap assessment, establish Quality Improvement Plans (QIP) and track progress:
  • Coordinate 3rd party and internal resources to conduct compliance gap assessments
  • Review recommendations and develop prioritization
  • Work with sites to establish QIP and to track progress
  • Prepare progress reports and dashboards as appropriate to ensure visibility to implementation of improvements

• Interface with Novo Nordisk support functions from Audits and Inspections:
  • Work with corporate audit team to manage internal audits
  • Build process to track regulatory signals at the acquisition sites
  • Participate in SME forums related to quality and compliance
  • Interact with CDMO Customers to support overall quality programs
• Member of AMI QA Quality Management Team:
  • Sit on quality leadership team for AMIQA Quality representing compliance
  • Establish visual management tools for leadership team to track performance
  • Serve as part of the ‘Ringfence” organization with access to sensitive client information
  • Support ‘above site’ processes as required through the period of department building
  • Access to customer sensitive and confidential information as required and ensure the information is handled confidentially a