Quality Control Information Technology Specialist

San Diego, CA, US
Sep 23, 2020
Biotech Beach
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 Quality Information Technology Specialist is responsible for Quality computerized system lifecycle management from concept, development, validation, implementation and maintenance to retirement. The incumbent will serve as subject matter expert for Quality computerized systems and ensure compliance to regulatory requirements such as 21 CFR Part 11 and Annex 11. In addition, the incumbent will be responsible for day-to-day management and continuous improvement of all QC computerized systems/processes in Novartis Gene Therapies.

  • Act as administrator for Quality computerized systems such as LIMS, Empower, and lab computerized systems including Windows permissions.
  • Plan and lead Quality IT projects, such as LIMS implementation and lab instrument qualification.
  • Work with Quality, IT, and Validation to support Quality computerized system lifecycle management activities from concept, development, validation, implementation and maintenance to retirement.
  • In addition to supporting base site, support a harmonized approach with team members across all network sites for Quality systems.
  • Author and review protocols, reports, investigations, non-conformance, CAPAs, and other records related to Quality computerized systems.
  • Monitor Quality computerized systems to ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11.
  • Assist with data integrity initiatives as they relate to Quality computerized systems.
  • Lead periodic reviews of existing computerized systems and identify process improvements coordinating implementation of new processes.
  • Create/maintain SOPs and training related to Quality IT systems.
  • Represent Quality IT during meetings. Communicates and tracks all follow-up items through to completion.

  • Bachelor's degree in a Scientific, Biotech, Pharmaceutical or IT field of study.
  • 8+ years working in a GxP pharma or biotech environment preferred.
  • 5+ years instrument administration experience preferred.
  • 3+ years' experience with LIMS administration, especially STARLIMS® preferred.
  • 3+ years' experience with chromatography data systems, especially Waters Empower® preferred.
  • Familiarity with Windows permission settings, network domain, and a general understanding of server architecture.
  • Prefer familiarity with SQL, Java, or other LIMS programming language.
  • Experience should include lifecycle management of Quality computerized systems.
  • Up to 10% travel required.

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