Our client, a cutting-edge biotech company dedicated to advancing solutions for rare diseases, are currently seeking a driven QC Manager to join their passionate team as they embark on an exciting growth trajectory in Switzerland.
Key Responsibilities:
- Quality Control Strategy: Develop and implement a comprehensive quality control strategy, aligned with the unique needs of rare disease therapies and biologics.
- Team Leadership: Lead, mentor, and manage a team of QC professionals, fostering a culture of excellence, continuous improvement, and compliance within the organization.
- Regulatory Compliance: Ensure strict adherence to regulatory standards, including GMP guidelines, and other relevant regulations specific to rare disease treatments.
- Quality Control Testing: Oversee and conduct routine quality control testing on biologic products, ensuring that they meet rigorous quality standards and specifications.
- Instrumentation Management: Manage and maintain laboratory equipment and instrumentation, including validation, calibration, and maintenance.
- Data Analysis: Analyze test data, evaluate results, and promptly report any deviations or discrepancies, initiating investigations and corrective actions when necessary.
- Documentation and Records: Maintain comprehensive and organized records of all quality control tests, results, and compliance documents.
- Quality Audits: Plan and participate in internal and external quality audits, addressing findings, and driving continuous improvement.
- Risk Management: Identify potential quality and compliance risks, and proactively implement risk mitigation strategies.
Qualifications:
- Bachelor's or Master's degree in a relevant life sciences discipline.
- A minimum of 8 years of experience in quality control within the biotech or pharmaceutical industry, with a strong focus on rare diseases.
- Profound knowledge of regulatory requirements, quality standards, and best practices specific to rare disease therapies.
- Strong leadership, analytical, problem-solving, and communication skills.
- Experience in managing quality control equipment and instrumentation is highly desirable.
Can this be interesting for you or anyone you know? If so, please apply here or contact Conor Kelly with your number/CV ASAP and he will give you a call.
?: +41 (0) 44 5514 407
?: c.kelly@panda-int.com