Senior Specialist, Quality Systems

Longmont, CO, US
Nov 11, 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.

The Senior Specialist, Quality Systems, collaborates closely with Manufacturing, Quality Assurance, Development, Quality Control, and Project Management teams to drive consistency in execution of non-conformances and change controls, drive continuous improvement initiatives and seek global alignments with other sites.

  • Plays an active role in establishing the site QS processes to support development and commercialization of new gene therapy medicines.
  • Drives consistency in execution of QS programs and participating in global initiatives to align QS processes at site level.
  • Works independently on problem solving, investigations, change control and implementation of preventative and corrective actions, working effectively within the group, within Quality, and across sites.
  • Serves as SME for Change Control, Non-Conformance and documentation programs.
  • Provides guidance and training to site users in QS processes.
  • Creates monthly QS site metrics, monitor, review and trend QS programs.
  • Leads Nonconformance and Change Control Review Board meetings.
  • Ensures all deviations and change controls are appropriately documented and investigated following QS program procedures and guidelines.
  • Reviews and/or author standard operating procedures and partner with operations on product related investigations and deviations.
  • Reviews and approve Change Control and Nonconformances.
  • Leads investigations to determine root cause of deviations and non-conforming results and implement appropriate corrective and preventative actions in a timely manner.
  • Identifies and implement new technologies to improve the compliance and efficiency of QS operations.
  • Participates in Site inspection preparation and response process.
  • Adhere to all GMP requirements.
  • Other related duties as assigned.

  • B.A. or B.S. in biochemistry or related scientific field with 7 years of experience in biopharmaceutical based GMP manufacturing operations.
  • Strong understanding of QS programs such as change control and nonconformance.
  • Understanding of FDA/EMEA regulations.
  • Direct experience reviewing and/or authoring standard operating procedures.
  • Excellent oral and written communication skills with strong technical writing experience required.
  • Potential for up to 20% travel.

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. #LI-MG1