May 10, 2022

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.

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Novartis Technical Operations
Full Time
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Quality Team Leader QC (Bioanalytics) ( 80-100%)*

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