344901BR
May 10, 2022
Switzerland

Job Description

BDSS QC Bioanalytics is an internal service lab (center of excellence) for Novartis manufacturing sites providing bioanalytical testing of Biopharmaceuticals for late-phase development projects and commercial products as a service. Applied analytical techniques are mainly cell-based potency assays for bioactivity determination and ELISA /qPCR for the determination of process-related impurities (e.g. host-cell proteins (HCP), residual Protein A, residual DNA).

We are looking for a highly motivated Quality Team Leader QC (Group Head) to lead the Bioanalytics QC team as operational and functional manager.

Main duties of this role include:

• Leading assigned associates as operational and functional manager including objective setting, periodic performance evaluation and Check-ins
• Support of associates continuous learning and personal development
• Leading of strategic improvement initiatives on group-, and department level
• Stakeholder management of internal and external customer (e.g. assessment of testing/resource requirements, setup of service level agreements, budget monitoring, continuous improvement and simplification of processes and workflows)
• Supervision of routine QC testing activities of bioanalytical methods for clinical and commercial products (release and stability testing), including line unit approval of analytical records, investigations of deviations, OOE/OOS, and analytical changes
• Support of technical project teams as analytical expert (e.g. for process validations, setting of specifications, clinical and market submissions, post-approval changes, health authority requests)
• Successful support in health authority inspections as subject matter expert (e.g. routine GMP inspections at Bioanalytics-QC or at the manufacturing sites, pre-approval inspections

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• PhD or equivalent education in Biology, Biochemistry, Chemistry, or related discipline
• 5-10 years of professional experience in the field of GMP production, QA or QC. Experience with Biopharmaceuticals desirable
• Thorough knowledge of cGMP requirements and quality metrics (KPIs)
• Results oriented, team player and able to work with all levels of the organization
• Strong people leadership and problem solving skills. Able to identify issues and develop business-friendly solutions in line with the overall compliance
• Experience in audits or inspections from health authorities
• Very good communication and presentation skills
• Fluent English required (oral & written); good skills in German

Over 799 million! - that's how many lives we reached with our products in 2022. And while we are proud of this, we continuously ask ourselves the question: how can we improve and extend even more lives in a world of digital and technological change? We are convinced that we can find answers if curious, courageous and team-oriented people are encouraged to question the status quo, make courageous decisions and follow innovative paths.


*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
https://talentnetwork.novartis.com/network
Novartis Technical Operations
NTO QUALITY
Switzerland
Basel
Quality
Full Time
Regular
No
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344901BR

Quality Team Leader QC (Bioanalytics) ( 80-100%)*

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