This is a temporary contractor opportunity at Novartis

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com

Ready to work with/through Magnit at Novartis? Please read on...

Role Purpose
As a QA manager of the QA Operational unit, manages complex projects and processes to support TRD drug development portfolio, drug production and/or life cycle management according to agreed objectives, timelines and standards. Ensure that compliance with cGMP is maintained in TRD.

Generic Activities
1. Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to the corresponding business partner (Line Unit) and other QA Units in area of responsibility
2. Write, review, decide on approval and/or release of GMP-relevant deliverables in order to ensure compliance with cGMP internal quality standards.
3. Perform project related activities, e.g. TRD products portfolio, operational processes, Quality Risk Assessments.
4. Support Project management functions as a project team member.
5. Provide Quality Oversight and support to TRD line functions in GMP related topics as per area of responsibility.
6. Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).

Specific tasks
Area of responsibility: TRD QA Operations
Specific activities:
- Release of batches, materials and components for clinical trials with issuance of batch certificates, and approval of development documentation with the authority defined as per related governing SOPs, and with authorities delegated by the TRD Quality Team Head or QA Switzerland Site Head (FvP)
- Oversight on the review of master and executed batch records performed by the QA specialists, including clarification of all deficiencies in GMP documents, and supervision of agreed follow-up.
- Write, review, and complete GMP relevant documents (e.g. CoAs, BRR checklists, SOPs, risk assessments).
- Supports audits and inspections in case of questions on assigned projects
- QA SPOC for assigned CMO. In this context, supports on-site visits and audit preparations at CMO, follows up audit CAPAs, and supports review of CMO KPIs and input to Quality agreements. Also responsible for collecting feedback from the various QA managers and support preparation of the Quality Risk Assess-ment (QRA). Is informed about deviations/OOX, general issues and changes at the CMO, and follows up at the corresponding meetings. Helps the QA managers and specialists for specific questions on CMO batch records/documentation and helps keeping harmonization of TRD QA Ops response.
Deputize for peers in the same area of responsibility
 

Education: Masters (5 years in pharma quality)

Languages: Fluent German and English required (oral & written)

Experience/Professional requirement:
Good knowledge of cGMP, working knowledge in technical development, production and QA.
Sound scientific, technical and regulatory knowledge.
Strong organizational and decision-making skills.
Strong and proven ability to analyze and evaluate cGMP compliance.

Workload: 40 hours/week
Role type: Basel on-site position (no remote) 

Why Novartis:  Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

Commitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Accommodation: If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com