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.

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

Job Purpose:
Lead complex projects and quality initiatives. Lead a small sub team as part of a matrix (could). Expertise in certain quality areas. Lead, guide and support global TRD project teams in all quality-relevant topics, questions, and issues. Develop project strategies in alignment with TRD considering all relevant cross-functional aspects to ensure the quality of deliverables within the project. QA representative at expert panel; Lead QA aspects of new technology projects; QA representatives for complex due diligence projects. Lead PAI and submission preparations, ensure inspection site readiness.

Main Activities:

• Lead and support global TRD project team, and represent TRD QA globally in TRD sub-teams, as well as at global quality board meetings and project development gate meetings.
• Ensure quality oversight on the assigned development projects with strong quality guidance, scientific and technical expertise.
• Contribute to the strategy of assigned projects incl. contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverables. Ensure that the strategy followed within the assigned projects is in line with TRD QA strategies and goals and in compliance to cGMP guidelines and internal procedures.
• Understand and proactively manage the interactions of project related activities between TRD QA and other departments inside or outside of TRD.
• Proactively communicate overall project strategy, key issues and any other critical topics in a timely manner to the appropriate management level, to the TRD project leader and/or to any other relevant project team member(s).
• Represent TRD QA in Due Diligence teams, provide quality assessment of potential in-licensing products in a timely manner and support follow-up activities as appropriate.
• Provide input to contracts and QA agreements with 3rd parties. Approve project-specific QA agreement amendments for assigned projects.
• Lead or participate in global and/or cross-functional initiatives.
• Prepare and guide TRD project teams for Mock-PAI and PAI in the frame of the PAI preparation process and submission preparation.
• Coach and mentor functional experts. Participate in recruiting process.

Additional specific Task/roles:

• Responsibilities, approval and release authorities as described in SOP-5003834
• QA support for Portfolio projects for Medical Device / Drug-Device Combination products (21 CFR 820 / CFR Part 4, ISO 13485) / SaMD /integration of BD&L projects / due Diligence on demand
• QA support in Audits/Inspections
• Ensure quality oversight on the assigned development projects and commercial distributed SaMD projects with strong quality guidance
• Initiate / lead / contribute in interface meetings with Device Development line units to handle and follow-up on general GMP /QMS relevant topics for continued improvement of processes

Ideal Background:
Education:
Bachelor +10 years’ pharma quality or operations or Masters +5 years’ pharma quality or operations

Languages:
Fluent English required (oral & written). Good skills in site (local) language desired (oral).

Experience /Professional requirement:

• Fundamental, broad understanding and knowledge of quality standards and policies in Drug Substance/Drug Product/Medical Devices manufacturing and control. 
• Experience with Health Authority Inspections (FDA and EMA in particular), and knowledge of RegCMC requirements for Health Authority submissions (INDs, IMPDs, NDAs, ANDAs, MAAs). 
• Broad experience in technical drug development as well as in Quality Assurance and/or Quality Control departments. 
• Experience in Technical Operations or equivalent experience from external company is preferred. 
• Proven track record in successfully leading interdisciplinary teams, e.g. scientists working on technical or methodological projects, in TRD or equivalent experience from external company or other line function. 
• Ability to contribute to matrix teams with the necessary strategic thinking, quality awareness and implementation skills. 
• Computer literacy (e.g. MS Office, document management systems) demonstrated along with readiness to learn new systems and associated processes.

Workload: 100% (40 hours per week)
Role type: Hybrid (2 days / week from home)
Contract: 12 months
Required start date: 1 September 2025

Important: No equipment will be provided, the use of personal laptop will be needed.

Why Novartis: 
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

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.