Specialist, Document Quality Assurance

San Diego, CA, US
Jul 21, 2021
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

Imagine\u2026 2 weeks after the birth of your child you realize they aren't meeting critical developmental milestones and after months of doctor's appointments you are told your baby has a rare neurological disease that would impact how they would live their lives.

This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it's the reason why we at Novartis Gene Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases.

We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich's Ataxia.

Imagine the lives you could transform by joining the Novartis Gene Therapy team.

The Document Quality Assurance Specialist is responsible for managing the GxP Document Control System ensuring compliance to quality objectives and regulatory requirements. The successful candidate is a quality focused individual who will work closely with SMEs to execute workflows and business processes that align with best practices. AveXis is searching for candidates who have the ability to be impactful and efficient.

  • Manage the preparation, routing, review, approval, distribution, and archival of new and revised controlled/managed documents.
  • Review documents submitted to ensure the correct use of templates, correctly entered metadata and document types.
  • Perform advanced word processing and assists GTx personnel in resolving document format issues.
  • Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedure.
  • Provides guidance and advice on approved procedures, standardization and requirements associated with the document management system.
  • Collaborates with cross-functional departments to ensure timely implementation of document change requests.
  • Provides training to new staff on document management system and document management processes and procedures.
  • Support audits (internal & external) in order to verify that regulatory and quality requirements have been met.
  • Organizes and ensures accurate and reliable filing systems for all paper-based GxP documents.
  • Maintain SOP binders.
  • Perform other duties as required.

  • Minimum of 4 years of technical writing/document control experience in the pharmaceutical/biotech industry.
  • Works under minimal supervision; requires a high level of independence.
  • Bachelor's degree or equivalent combination of related education and experience.
  • Excellent knowledge of understanding of applicable GxP regulations.
  • Experience with Electronic Document Management Systems and is proficient with the Microsoft Office suite (ie, Word, Excel, Visio, PowerPoint, etc.) and Adobe.
  • Demonstrates ability to perform detail-oriented work with a high degree of accuracy.
  • Effective written and oral communication skills.
  • Effective time management and interpersonal skills.
  • Possesses initiative and is proactive.

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

Why Novartis?

769 million lives were touched by Novartis medicines in 2020, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!

Novartis Gene Therapies Benefit Summary:

Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.

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