Director, External Quality Assurance - CMO/CTL

Location
Durham, NC, US
Posted
Sep 30, 2020
Ref
5633
Hotbed
Bio NC
Required Education
Bachelors Degree
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.

Novartis Gene Therapies is seeking a Director, External Quality Assurance, responsible for quality assurance oversight of all external CMO, Contract Laboratories and critical Starting Material Manufacturer activities, including but not limited to providing quality leadership for Tech Transfers between sites and CMOs, supporting major/critical investigations and supporting inspections.

Responsibilities
  • Leads and manages resources and budget within External Quality and drives an ongoing organizational transformation towards the future Novartis Gene therapy strategic horizon.
  • Provides leadership, mentoring and coaching for the subordinates in the External Quality team; supporting their career development in line with the business needs in the External Quality Department and/or the overall Novartis Gene Therapy Quality Organization.
  • Partners with and leverages similar expertise in Novartis Group Quality Organizations (e.g. ESO) and identifies opportunities for External Quality process optimizations and continuous improvements.
  • Identifies critical compliance and/or business issues related to CMOs, Contract Laboratories and Manufacturers of critical starting materials. Creates remediation strategies and tactical plans as needed using a risk management based approach.
  • Participates as a core member in the External Manufacturing team providing the Quality Assurance oversight.
  • Partners with internal Stakeholders: External Supply Organization, Supply Chain, Manufacturing Science & Technology, Manufacturing Operations, Regulatory Affairs, Global Quality Functions in Novartis Gene Therapy and Novartis Group.
  • Collaborates with External Partners: CMOs, Contract Laboratories and critical starting materials Manufacturers to ensure uninterrupted supply ensuring full support to current and future Novartis Gene Therapy Manufacturing.
  • Supports the major/critical deviations and events investigations minimizing risk on product quality, efficacy and safety.
  • Leads escalations related to External Quality activities for critical issues.
  • Supports the inspection readiness program in regards to CMOs, contract Laboratories, critical starting materials suppliers and coordinates responses needed for External Quality topics.
  • Creates and maintains External Quality metrics.
  • Other Job related duties determined during the annual objectives setting process and by the key performance indicators.

Qualifications
  • B.S. degree, preferably in microbiology, chemistry or biochemistry. M.Sc. is preferred.
  • Minimum 10 years of experience in a pharmaceutical or biologics with a minimum of 5 years' experience in Quality Operations and/or external Manufacturing management.
  • Biologics or vaccines experience is preferred.
  • Minimum of 5 years of direct supervisory experience with budget management.
  • Comprehensive knowledge of FDA and EMA regulations and experience in interaction with US and international regulatory agency inspections.
  • Experience in identifying compliance gaps, writing, evaluating and closing investigations with strong technical writing experience.
  • Excellent communication skills.
  • Excellent quality critical thinking.
  • Managing Projects and/or Operational Excellence experience is preferred.
  • Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
  • Domestic and international travel required (up to 25%)


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, #JOBS, #CAREERS, #HIRING