Senior Director, Quality

Novo Nordisk•Boulder, CO

5d•Onsite

About 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.

Requirements

Bachelor's degree from an accredited university and 14+ years of experience required.
Equivalent experience requirements for advanced degrees would be a Master's 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

Nice To Haves

Knowledgeable in systems within pharmaceutical industries to include drug production and/or Active Pharmaceutical Ingredient (API) preferred

Responsibilities

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
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
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
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
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
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
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
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.