Team Lead Quality Control Biotesting, Process Monitoring & Validation | Teamlead QC Biotesting Process Monitoring & Validation (m/w/d)
Roche Diagnostics GmbH
Job Summary
As the Team Lead for QC Biotesting, you will oversee a team of 13 professionals within the Sterile Drug Product Manufacturing (SDPM) division at Roche. Your primary responsibility is to ensure GMP-compliant, efficient, and timely quality control for microbiological testing and bioassays. This includes monitoring production environments and water systems, validating sterilization and decontamination processes, and managing media fills and germ identification. You will act as a coach and mentor, fostering a culture of self-organization and continuous improvement through Lean Production System (LPS) methods. The role is highly collaborative, requiring you to coordinate with various departments and participate in global projects focused on automation, Industry 4.0, and digital pharma. This position is ideal for a leader who thrives in a VUCA environment and is passionate about delivering life-saving medications to patients through innovative quality control strategies.
Required Skills
Education
University degree in Natural Sciences (minimum Master's degree, preferably in Biology), ideally with a focus on Microbiology.
Experience
- Minimum 5 years of professional experience in pharmaceutical quality control or a GMP-regulated environment
- Proven leadership experience as a manager or team lead, focusing on employee development and coaching
- Extensive experience in cleanroom monitoring and validation of aseptic and sterilization processes
- Professional experience in germ identification methods and handling bioindicators
- Experience working within global, interdisciplinary teams and managing complex stakeholder relationships
- Demonstrated experience in implementing Lean methodologies and driving process optimization
Languages
Additional
- The role requires a strong understanding of Industry 4.0 and Digital Pharma trends. Candidates must be able to work in a VUCA (Volatile, Uncertain, Complex, Ambiguous) environment and demonstrate an 'End-to-End' entrepreneurial mindset.
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