Senior Method Validation Manager – m/w/d

Responsibilities

• In a central role you will take on the strategic planning, leadership and active execution of method development and validation in accordance with ICH, USP and Ph. Eur.
• Throughout the entire lifecycle, you ensure that existing test methods remain fit for purpose – from monitoring and optimization to revalidation.
• Scientific quality and regulatory compliance are at the forefront, ensuring that test methods meet GMP, ICH and ISO requirements at all times.
• You reliably and purposefully coordinate method transfers between internal and external laboratories as well as transfers to new instruments.
• You interpret validation data with sound judgment and evaluate parameters such as precision, accuracy, linearity and robustness.
• You apply statistical methods strategically to detect and evaluate trends and deviations at an early stage.
• You prepare, review and approve validation plans, reports, SOPs and work instructions, thereby ensuring a clear, traceable documentation base.
• You always keep an eye on compliance with data integrity requirements (ALCOA+) as well as GMP‑compliant documentation and data storage.
• You contribute your expertise and confidently support regulatory inspections (e.g. EMA, FDA, Notified Bodies).
• In close collaboration with Quality Assurance, Regulatory Affairs, Production, Development and external partners, you drive topics forward together.

Requirements

• Degree in Life Sciences/Natural Sciences (e.g., Chemistry, Pharmacy, Biology) or a comparable scientific-technical qualification with further training and relevant professional experience (e.g., chemical technician)
• Several years of experience in analytical development, quality control or method validation in a GMP-regulated environment, as well as knowledge of relevant standards and regulatory requirements
• Very good German and English skills
• Good IT skills (MS Office, LIMS, CDS, document management systems and instrument software)
• Team player