Senior Quality Assurance Specialist, External (CMO/CTL)

Location
Durham, NC, US
Posted
Aug 21, 2020
Ref
5420
Hotbed
Bio NC
Required Education
Masters Degree/MBA
Position Type
Full time
Overview

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 QA Specialist, External- Manufacturing or Testing (CMO/CTL) is responsible for quality oversight of Novartis Gene Therapies Contract Manufacturing Organization (CMO) and/or Contract Testing Laboratory (CTL) partners. This position will be responsible for making quality decisions, addressing and/or resolving problems based on written procedures and analysis. Will be responsible for communicating all issues effectively and promptly to all levels of the organization, as well as other departments such as Supply Chain, External Manufacturing and Project Management.

Responsibilities

Two positions available; one position overseeing Contract Manufacturing Organization (CMO) partners and one position overseeing Contract Testing Laboratory (CTL) partners.
  • Responsible for ensuring the conformance of the CMO's manufacturing, packaging, or testing processes to cGMP, company policies and procedures, as well as Novartis Gene Therapies' specific requirements
  • Responsible for ensuring Quality Oversight of Contract Testing Labs in alignment with Novartis Gene Therapies policies and procedures.
  • Direct support of Novartis Gene Therapies release of intermediate and final product material manufactured by CMO's and/or approval of analytical method testing.
  • Review and approve manufacturing batch records, QC and EM records as well as associated records such as deviations, investigations, CAPAs and change controls
  • Review and approve master production records, material specifications, testing protocols, and validation protocols as necessary.
  • Partners with cross-functional Novartis Gene Therapies team as well as external teams at CMOs/CTLs to resolve documentation and batch related issues
  • Provides cGMP observations to management and escalates issues / challenges as needed to manager
  • Provides critical quality expertise to transition a novel gene therapy into a commercially approved product. This individual must have a strong knowledge and application of the CFR's and cGMP's.
  • Other duties as assigned

Qualifications
  • Bachelor's degree required in Chemistry, Biochemistry or similar technical disciplines
  • A minimum of 5 years of experience in pharmaceutical-based GMP manufacturing operations including direct experience in documentation review
  • Previous experience with viral gene therapies and/or orphan disease indications is a plus
  • Knowledge of clinical trials and commercial manufacturing as well as analytical methods. This individual must have a strong knowledge and application of the CFR's and cGMP's
  • High level of accuracy and attention to detail
  • Good written and verbal communication skills with the ability to convey information clearly and accurately
  • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward; ideal applicant will be required to demonstrate high attention to detail, multi-tasking, and organization ability
  • Good problem-solving and analytical skills
  • Proficiency in and knowledge of MS Office, deviation and CAPA management software, and document management systems.

Domestic and international travel required (15%)

This position will be located out of our Chicago (IL) or RTP (NC) office.

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