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Deviation Leader & Coordinator

Employer: Novo Nordisk
Location: West Lebanon, NH
Start date: Jul 5, 2024

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Discipline: Clinical, Clinical Project Management
Required Education: Bachelors Degree
Position Type: Full time
Hotbed: Best Places to Work

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Job Details
Company

Job Details

About the Department

Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do. We’re looking for individuals who are self-starters with a strong work ethic to join our team. At Novo Nordisk, you will find opportunities, resources and mentorship to grow and build your career. Are you ready to realize your potential?

The Position

The Deviation Leader/Coordinator is responsible for the quality and oversight of the deviation investigation and CAPA (corrective actions and preventive actions) management processes. The Deviation Leader is also responsible for fostering a learning culture within the Deviation Investigation organization and working with site leadership to strengthen and support a learning culture across the site. This role involves leadership and supervision of the investigation team, ensuring deviation investigation approaches are appropriate and suitable to the business's operations and communicating and escalating deviation priorities, risks, and impacts to site leadership and other key stakeholders. Will also be responsible for leading investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with operational deviations and a champion for quality priority principles and compliance within the organization.

This is an onsite based role with relocation assistance eligible for selected candidate.

Relationships

Reports to: Director of MSAT & Quality Control

Number of subordinates with direct/indirect referral: Incumbent will have mix of direct and indirect-matrixed investigators as subordinates

Essential Functions

Assess the current state of deviation investigations and creation/assignment of CAPA. Identify recurrent deviation types and potentially ineffective CAPA and introduce new investigation techniques and/or improve the effectiveness of current investigation techniques

Manage site deviation metrics and leading indicators, including target ranges for the number of open deviations as well as deviation and deviation action closure times

Facilitate weekly/daily management review of deviation metrics. Create processes to identify response actions and track accountability for completion of actions

Create and deploy process to assess deviations and assign investigation and approval team within one business day of initiation

Refine CAPA effectiveness check process to ensure that investigations identify meaningful causes that map to actionable and effective CAPA that reduce recurrent deviation types

Lead and supervise the deviation investigation team, assign deviations based on investigator skill/experience and deviation type, ensure level-loading of investigator workload, and identify and support training and development opportunities to advance investigators’ skillsets. Mentor and coach investigators

Identify and deploy advanced investigational techniques to support more effective investigations and identification of meaningful causes. Examples may include human and organizational performance, advanced interview techniques, standardized data collection methods, branching cause maps, and other methods

Maintain expertise in deviation investigation best practices through ongoing training and participation in industry associations

Collaborate with site leadership to ensure the deviation process is supporting high-level organizational goals and outcomes

Partner with site leadership to identify opportunities to support a learning culture within the organization, so that processes are improved, and error opportunities are identified and corrected in a pre-deviation state

Lead cross-functional investigation teams to identify root cause, evaluate technical impact, and provide recommendations to management on batch disposition

Manage and author investigations to meet key timing commitments, with well-investigated and well-documented deviation reports

Develops a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps

Provide mentorship to deviation management team members

Acts proactively to ensure standardized process operations and promote team collaboration

Provide follow-up and scheduling to ensure the batch release process is not impacted by outstanding deviations

Ensure investigations will comply with internal NN requirements and are compliant with cGMP regulations

Update SOPs or other official documents as required

Support other quality compliance and implementation projects, as assigned

Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes

Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others

Physical Requirements

Local and international travel up to 10% of the time. Prolonged periods of sitting or standing at a desk and working on a computer. Must be able to lift up to 15 pounds at times. Ability to gowning and work in clean room areas for investigations. Off-shift work may be required.

Development of People

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

Education and Certifications:
B.S. degree in related engineering/scientific field. M.S. preferred
Certification in Six Sigma or other process improvement methodology is preferred

Work Experience:

Minimum 2 years of experience directly leading and supervising

Minimum 3 years of experience conducting deviation investigations in a cGMP pharmaceutical manufacturing environment with a Bachelors

Minimum 3 years of technical and/or investigative writing with demonstrated proficiency in implementing effective CAPAs based on investigation results

Minimum 7 years total experience supporting cGMP pharmaceutical manufacturing, either in manufacturing or in a direct support role with a Bachelor’s degree or minimum 5 years’ experience supporting cGMP pharmaceutical manufacturing, either in manufacturing or in a direct support role with a Master’s degree

Strong understanding of US and international cGMP regulations governing pharmaceutical manufacturing, and in the application of such regulations

Familiar with Lean Six Sigma methodologies and proven analytical/problem solving capabilities, analysis of complex problems through critical analytical thinking

Proficient in the use of problem solving tools: A3, 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, Human Error Reduction

Demonstrated ability of meeting goals/timelines/organizational skills

Experience in API Manufacturing preferred

Knowledge, Skills, and Abilities:

Technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech industry. Experience with deviation or investigation management systems

Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report

Experienced in troubleshooting, investigation, and root-cause analysis in a cGMP environment

Ability to evaluate data and make recommendations based on data analysis

Must be familiar with health authority (FDA) requirements

Ability to work in a fast-paced environment with the capability to prioritize effectively to meet timelines

Facilitation and coaching skills

Strong technical writing skills

Excellent organizational, communication and interpersonal skills, and the ability to interact with all levels of management, vendors, and employees from the shop floor to global leadership

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Company

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by 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. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

CONNECT

Company info

Website: https://www.novonordisk-us.com/
Phone: 617-612-6200
Location: 75 Hayden Avenue
Lexington
MA
02421
United States

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