Senior Scientist, Compliance and Maintenance Support Quality Control Full-time

Senior Scientist, Compliance And Maintenance Support (Quality Control)

The Senior Scientist, Compliance And Maintenance Support (Quality Control) plays a critical role in ensuring that QC processes, equipment, and analytical systems are designed, maintained, and operated in full compliance with regulatory and health authority requirements. This position acts as a subject matter expert (SME) for QC equipment maintenance and compliance activities, supporting inspection readiness, laboratory operations, and the lifecycle management of QC systems.

Key Responsibilities

Compliance & Regulatory Readiness

• Act as Investigator for deviations and assigned Change Controls.
• Author, review, and update GMP documentation.
• Perform gap assessments and support the definition and execution of remediation actions.
• Actively support inspection and audit readiness for health authorities and customers, including participation in inspections and audits.

QC Equipment & System Support

• Serve as Subject Matter Expert (SME) for QC equipment maintenance.
• Coordinate and oversee maintenance activities for QC laboratory equipment.
• Support qualification and re-qualification of existing and new QC equipment.
• Support the lifecycle management of QC systems (equipment and applications)

Laboratory Support & Troubleshooting

• Provide expert support to QC laboratories in the event of deviations, OOX/OOS investigations, Change Controls, and technical troubleshooting.
• Collaborate closely with QC, Engineering, IT, and Quality functions to ensure robust and compliant solutions.

Who We Are Looking For

Education

• Bachelor's or Master's degree in Molecular Biology, Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.
• Equivalent professional experience may be considered in lieu of formal education.

Experience

• Minimum 5 years of experience in a GMP-regulated laboratory environment.
• Strong hands-on experience with analytical laboratory equipment, including maintenance coordination.
• Proficiency in technical English, German is an advantage.

Skills & Competencies

• Strong commitment to quality, compliance, and data integrity.
• Highly detail-oriented with a structured, risk-based approach to problem solving.
• Ability to work independently while collaborating effectively across cross-functional teams.
• Excellent communication, organizational, and prioritization skills.
• Strong interest in digitalization and modernization of analytical systems.
• High level of motivation to continuously develop technical and regulatory expertise.