Manager, Supplier Quality Assurance (SQA)

Location
Durham, NC, US
Posted
Sep 24, 2020
Ref
5448
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.

The Manager, Supplier Quality Assurance, contributes to our SQA operations as we continue to develop and maintain supplier quality standards to ensure Novartis Gene Therapies products are manufactured to relevant patient safety and product quality standards in line with business requirements.

Responsibilities
  • Support the Supplier Quality function responsible for delivering all aspects of the Supplier Quality Assurance.
  • Support/Manage Global Supplier Quality core processes; supplier and material qualification for new and existing suppliers, quality agreements, supplier maintenance/periodic assessments, supplier monitoring, and supplier change notifications.
  • Plan, manage, and support supplier audits.
  • Approve and maintain supplier and material data in the appropriate electronic systems (quality and inventory management).
  • Manage supplier quality related issues and facilitate the escalation of unresolved supplier quality issues within assigned projects and suppliers.
  • Communicate clearly (written and verbal) to all levels within the organization on quality related topics.
  • Identify nonconforming events, perform root cause analyses, and identify solutions with cross functional teams. Support resolution and closure of Supplier Quality related corrective and preventive actions.
  • Collaborate with the Global Strategic Sourcing team on new supplier introduction and supply chain initiatives.
  • Monitor and regularly report supplier product quality and performance to appropriate QA Leadership and Business Partners.

Qualifications
  • Bachelor's Degree required in a scientific discipline.
  • 6 years' experience in Biotech/Pharmaceutical industry, with at least 3 years' directly supporting the Supplier Quality Assurance function.
  • Preferred experience in managing GCP/GPvP suppliers, third party logistics, transportation couriers, and cold chain logistics.
  • Understanding of common biologics and sterile chemical materials manufacturing processes is strongly preferred.
  • Hands on knowledge of quality management and business systems for managing suppliers and materials.
  • Strong knowledge of GMP (US, EU and APAC) as well as ISO standards with regards to material and service providers.
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiency.
  • Ability to work in a diverse and dynamic environment.
  • Ability and willingness to embrace change and adapt current processes while maintaining compliance and quality requirements.
  • Good communication and interpersonal skills.
  • Certification in PMP, CQA or ASQ is highly desired.
  • Ability to travel up to 20%.

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