Senior Method Validation Manager – m/w/d

Jobtailor; Wehrheim; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks an experienced professional to lead method development and validation, ensuring GMP-regulated compliance and fit-for-purpose testing methods.

You will coordinate transfers between internal and external labs and to new instruments, and you will support regulatory inspections while collaborating with QA, Regulatory Affairs, Production and Development teams.

Qualifikationen

• Qualified in life or natural sciences with further training and relevant professional experience (e.g., chemical technician).
• Several years of experience in analytical development, quality control or method validation in GMP-regulated environments.
• Very good German and English skills.
• Good IT skills including MS Office, LIMS, CDS and instrument software.
• Team player with collaborative mindset.

Aufgaben

• 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.
• Coordinate method transfers between internal and external laboratories and to new instruments.
• Ensure test methods remain fit for purpose through monitoring, optimization and revalidation.
• Ensure compliance with GMP, ICH and ISO requirements and data integrity (ALCOA+) in documentation and data storage.
• Support regulatory inspections (e.g. EMA, FDA, Notified Bodies).
• Collaborate with Quality Assurance, Regulatory Affairs, Production, Development and external partners to drive topics forward.

Kenntnisse

German language

English language

Team player

Ausbildung

Life Sciences/Natural Sciences degree

related scientific-technical qualification

Tools

MS Office

LIMS

CDS

Document management systems

Instrument software

Jobbeschreibung

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