Director - Product Quality

Research & Development Organization

Our Research & Development organization brings together the best minds in life science innovation. The teams located in Lexington, Watertown, Cambridge, and Seattle 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 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 Position

Oversee the CMC QA Organization for the site, which includes responsibility for the Quality Assurance (QA) function and serves as the leading expert in quality, compliance, and quality management systems (QMS). Provide direction & coordinate the Quality organization activities to support the business progress. 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. Coordinate with leadership team & other relevant stakeholders to ensure strong communication & aligned priorities on short / medium / long range.

Essential Functions

• 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
• Responsible for ensuring compliance with all regulatory requirements and maintaining the highest standards of quality assurance within the organization
• Participate as a member of Quality Leadership Team in setting quality goals, objectives & policies, which includes ensuring the quality goals align to the respective site's goals
• Meet or exceed business, regulatory & internal customer requirements in accordance with Novo Nordisk Way
• Provide expertise on Good Manufacturing Practice compliance
• Ensure technical training & development on Quality Management is in place across the site
• Direct, coach & manage site quality management team, which includes but is not limited to training & development, performance management / review & development planning, talent recruitment / selection, managing employee relations, overseeing financial matters and driving continuous process improvement & projects
• Maintain effective communication, collaboration & alignment across stakeholders, site management & global partners
• Ensures coordination and oversight of internal audits and external inspections of CMOs
• Follow all safety & environmental requirements in the performance of duties
• Other accountabilities, as assigned

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

Bachelor's degree in science, engineering, business, or relevant field of study from an accredited university required, with a minimum of ten (10) years of experience in pharmaceutical quality, active pharmaceutical ingredient (API) industry, manufacturing or a related area required. Master's degree in science, engineering or business field preferred. 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 parenteral 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.

Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process. The base compensation range for this position is $181,670 to $317,920. 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 position's 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, flexible vacation policy, and parental leave policy. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.