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 KPIs 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 cases potential recalls and authority inspections

• Management & Leadership task:
  • Make decisions independently and through direct reports in all people related matters including salary bonus tasks assignments and employment
  • Maintain effective communication collaboration & alignment across stakeholders site management & global partners
  • Foster an innovative environment for constantly improving way of working and ensure robust and simple solutions
  • Manage annual activities according to agreed timelines: QMR BR Salary Bonus Organizational Development Budget
  • Drive people engagement and well-being to ensure a healthy organization
• Effective organization people and resource management:
  • Responsible for organizational effectiveness of department
  • Responsible for allocating sufficient economic resources and managing these through the line budget and investment budget so that the cost targets are met at the same time as the key deliverable targets are reached timely
  • Responsible for establishing and continuously optimizing the department by effectively managing and setting direction incl. Recruiting the right leadership to the key positions in the area & establishing a clear organizational structure and effective decision-making processes
  • Effective recruitment and development of QA competences to close existing and predicted core competence gaps in the area

• Scope of Authority:
  • Make independent decisions within own department/area
  • Make decisions independently and through Directors in all people related matters including salary bonus tasks assignments development training and employment
  • Secure local QMS maintenance in compliance with the Novo Nordisk Quality Manual and Novo Nordisk Procedures
  • High degree of ability to make independent decision required representing Novo Nordisk in an international context under sometimes challenging conditions due to cultural national or political restrictions when operating
  • High degree of influence on Department and CVP area results regarding various performance goals
  • Bring concerns to the surface which can have impact on performance and impact critical project timelines
  • Ensure cGMP and trends within the area and best practices are shared within Novo Nordisk for benchmark and inspiration
  • Speak and act with authority in connection with critical case e.g. product defects and potential recalls and when representing NN during inspections and audits
  • Authority to approve purchases and investments according to NN approval level

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role.)

Development of People

Supervisory. Ensure that reporting personnel have individual development plans (IDP) with annual goals and measurements that are consistent with the priorities of the business and that interim reviews are held so that their work is focused on those priorities and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies procedures and Novo Nordisk Way.

Qualifications

• Bachelors degree from an accredited university and 14 years of experience required. Equivalent experience requirements for advanced degrees would be a Masters degree and 12 years of experience a PhD and 10 years of experience or MD/DO and 5 years of experience
• Minimum of five (5) years managing other managers required
• Excellent working knowledge of GMP regulations relevant to the business required
• Knowledgeable in systems within pharmaceutical industries to include drug production and/or Active Pharmaceutical Ingredient (API) preferred
• Proven expertise in mentoring/development required
• Excellent written & verbal communication skills required
• Strong presentation skills required
• Proven expertise in mentoring/development process confirmation change management planning/organizing & managing execution required
• Demonstrated ability to review complex organizational plans & provide any required or necessary guidance to ensure success required
• Proven process improvement & problem-solving skills required

The base compensation range for this position is $229200 to $401100. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the positions level or other company factors.

Employees are also eligible to participate in Company employee benefit programs including medical dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal critical illness identity theft protection pet insurance and auto/home insurance. The Company also offers time off pursuant to its sick time policy flex-able vacation policy and parental leave policy.

The job posting is anticipated to close on May 5. The Company may however limit or extend this time-period in which case the posting will remain available on our careers website at-us/.

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

At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and defeating diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.

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-. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.