Job Description Summary
The QC Lead Microbiology & Aseptic Processes is responsible for ensuring compliance with cGxP standards within the area of responsibility (during development, transfer and commercialization), including safety testing, monitoring and trending.
Provide advice, support and leadership for the implementation of test methods, specifications and analytical standards.
Specific focus on Aseptic controls and sterility assurance in line with EU GMP Annex 1.
Job Description
Deadline for applications: 24th of April 2026.
Major accountabilities:
- Lead the QC Microbiology and Aseptic Processes team, ensuring all laboratory activities are carried out in compliance with cGxP standards and internal quality requirements.
- Ensure timely testing of incoming samples and smooth daily lab operations by setting priorities, monitoring workflow, and resolving operational issues when needed.
- Manage staffing, team capacity, and training, making sure there are enough qualified people in place to complete all operational tasks effectively.
- Oversee stability management and key quality documents, including reviewing and approving protocols, SOPs, and analytical procedures, and keeping them up to date.
- Provide people leadership and coaching by mentoring team members, supporting their development, promoting company values, and building a motivated, accountable team culture.
- Manage the department’s budget and financial targets, including headcount, supplies, external service invoicing, and planning for future investments and hiring.
- Ensure strong compliance and audit readiness by supporting inspections, handling deviations, contributing to investigations, and defining and implementing CAPAs.
- Promote safety, environmental responsibility, and continuous improvement, including risk reporting, support for HSE initiatives, process optimization, innovation, and new product launches.
Obligatory Requirements:
- Education: Ideally Master’s degree in a scientific field.
- Minimum 5 years of experience in the pharmaceutical industry, preferably in a GMP or GLP environment.
- Strong leadership skills with experience in coaching and guiding teams.
- Solid project management and coordination abilities.
- Effective stakeholder management and excellent communication skills.
- Strong problem-solving mindset with a focus on operational excellence.
- Able to work well under pressure and remain stress-resistant.
- Fluent in Dutch, with good verbal and written knowledge of English.
Commitment to Diversity and Inclusion
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Skills Desired
Business Acumen, Business Strategy, Collaboration, Communication Skills, Data Integrity, Dealing With Ambiguity, Digital saviness, Finance Acumen, Leadership, Manufacturing Production, Problem Solving Skills, Regulatory Requirements knowledge, Smart Risk Taking, Stakeholder Management
