Senior Director, Quality

About the Department

The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts.  Together, we are driving change. Are you ready to make a difference.

The Position

The Senior Director, Quality is the highest quality authority at site Boulder and point of contact for authorities such as e.g. FDA and responsible for qualification and operational readiness of new manufacturing facility for siRNA for Phase I and Phase II to ensure delivery of clinical material from internal GMP plant in 2027 as well as ensuring clinical material delivered and dispositioned from oligo CDMO network to continue ongoing and new clinical trials in the Oligo space. The Senior Director, Quality is responsible for the CMC QA Organization for the Boulder, CO site, which includes responsibility for the Quality Assurance (QA) function, quality oversight, compliance, audits/inspections, validation and quality management systems (QMS) aspects. Develop and drive strategic agenda for the Quality organization activities to support the business progress and ensure quality as a competitive advantage. Formulate, communicate and implement the QA strategy that supports the manufacturing and testing of clinical products at CMO partners. Plan and execute qualification and operational readiness initiatives required to support clinical API internal manufacturing within the new facilities currently being build on site. The Senior Director, Quality is part of LT team in Boulder as well as being part of CMC Quality leadership globally. Coordinate with leadership team & other relevant stakeholders to ensure strong communication & aligned priorities on short/medium/long range.

Relationships

Reports to Vice President.

Essential Functions

• Performance:
  • Overall responsible for the direction and quality strategy at site Boulder
  • Drive strategic development of people and organization to fulfil business needs and strategic priorities and ensure a well-functioning and effective department
  • Serve as key partner for site leadership, managing business integration & site strategy to support manufacturing of clinical product through testing and quality programs to ensure product safety and quality
  • Ensure a close and smooth collaboration with key internal stakeholders to ensure alignment and a common picture of quality activities, responsibilities, and future demands
  • Overall Responsible for leading the Quality culture in collaboration with CMC leadership team and to ensure that CMC meets the Novo Nordisk Quality Policy, QMS, and Quality objectives
  • Follow all safety & environmental requirements in the performance of duties
  • Other accountabilities, as assigned
• Budgeting and Allocation of Resources:
  • Budgeting and following up on costs and investments
  • Take part in planning and follow-up on budgeting and investments, covering the department
  • Strive to eliminate bottlenecks and secure an optimal utilization of resources and equipment

• Quality responsible:
  • Ownership of the Quality Agenda in CMC Boulder
  • Responsible for CMC Boulder QA KPI´s, budget and process efficiency
  • Responsible for ensuring compliance with all regulatory requirements and maintaining the highest standards of quality assurance within the organization
  • Meet or exceed business, regulatory & internal customer requirements in accordance with Novo Nordisk Way
  • Provide expertise on Good Manufacturing Practice compliance
  • Ensures coordination and oversight of internal audits and external inspections of CMOs
• License to operate:
  • Oversight of area to ensure valid GMP certificate and License to Operate with local Health Authorities at all time
  • Secure regulatory compliance and inspection readiness within area of responsibility
  • Provide requested information from RA to regulatory authorities worldwide, e.g. Local authorities, FDA, EMEA, PMDA, ANVISA, CFDA and others
  • Key person in relation to critical