Manager, Process Investigations (Non-Conformances)

Longmont, CO, US
Oct 02, 2020
Required Education
Bachelors Degree
Position Type
Full time

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

With cutting-edge technology, we are making progress in the treatment of rare and life-threatening neurological genetic diseases. Our initial gene therapy for spinal muscular atrophy (SMA) has been approved in the U.S., Japan, EU and Brazil.

The Manager, Process Investigations, is responsible for leading the Process Investigations Group that is accountable for the initiation, documentation, investigation and completion of non-conformances, focused on identification of root cause, and implementation of corrective actions and preventive actions.

  • Analyzes trends using statistical method.
  • Authoring/Owning/Ensuring investigations related to cell culture, purification, facilities and engineering.
  • Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOPs), batch records and white papers.
  • Perform/Review appropriate root-cause analysis for events utilizing investigation tool (e.g., 5 whys, Fishbone Diagrams).
  • Assign proper corrective action and preventive action (CAPA) to resolve and prevent recurrence of events.
  • Utilize appropriate risk management tools for recommendation on disposition of materials.
  • Present completed investigations for final approval.
  • Performance of risk assessments.
  • Meeting facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward.
  • Conflict resolution, problem solving in a cross functional setting, and ability to meet timelines for closure of exception events.
  • When required, works on the manufacturing floor for data gathering, observing of processes for investigations, and interviewing Novartis Gene Therapies employees.
  • Conducts personnel interviews and system reviews. Acts as an unbiased investigator with questions surrounding the specific issue.
  • Remains current in regulatory expectations and industry practices regarding investigations and CAPAs.
  • Tracks, trends and facilitates all manufacturing related deviations, investigations and CAPAs.
  • Supports Manufacturing and Quality to assist in the data collection from Manufacturing and preparation of necessary documentation to support Annual Product Reviews.
  • Hires, manages, leads and coaches team.
  • Drive continuous process improvement of manufacturing processes, investigation processes, etc.
  • Provides direct technical/managerial leadership to Process Investigations group.
  • Represents Process Investigations Team on the monthly Quality Management Review meetings.
  • Presents investigations to regulatory agencies during inspections.
  • Other related job duties as assigned.

  • Bachelor's degree in science or related field and 8 years of relevant experience or 12 years equivalent combination of education and experience.
  • Strong working knowledge of biopharmaceutical manufacturing processes
  • Excellent skill set in using statistical methods for analysis.
  • Ability to manage multiple ongoing projects concurrently.
  • Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
  • Works in a cGMP environment and must have ability to understand and problem solve in an environment that is focused heavily on Biological issues.
  • Understanding of the concepts incorporated in Quality Assurance in a GMP environment.
  • Excellent leadership and supervisory abilities.
  • Strong meeting facilitation and conflict resolution skills.
  • Strong technical writing capability is required.
  • Manufacturing, specifically upstream and downstream processing in a GMP environment is preferred.
  • Prior experience in quality investigations and deviation writing in a manufacturing environment.
  • Must have the ability to work in a fast paced, high workload environment, and be able to manage multiple projects and objectives for on-time event closure.
  • Must work well on a team and be able to trouble shoot and problem solve in a cross-functional team setting.
  • Must be proactive, action oriented, and have the ability to adapt to change.
  • Must be able to identify and flag risks in a timely manner to keep deliverables on track.
  • Must have strong communication skills both verbally and written.
  • Must have proven logic and decision-making abilities, critical thinking skills.
  • Must have strong Microsoft Office Suite (Word, Excel, and PowerPoint) skills.
  • Familiarity with Operational Excellence/LEAN constructs a plus (e.g. Six Sigma belt, Practical Problem Solving)

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.