Deviation Leader - West Lebanon, United States - Novo Nordisk

Novo Nordisk

Verified Company

West Lebanon, United States

1 day ago

Posted by:

Mark Lane

beBee recruiter

Description

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.

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 levelloading 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 highlevel 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 predeviation state
Lead crossfunctional 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 wellinvestigated and welldocumented 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 followup and scheduling to ensure the batch release process is not impacted by outstanding deviations
Ensure investigations will comply with