Senior Method Validation Manager – m/f/d

Jobtailor; Wehrheim; Vor Ort; EUR 75.000 - 95.000; Vollzeit

Zusammenfassung

Jobtailor in Germany seeks an experienced professional to lead method development and validation in a GMP-regulated setting. You will drive transfer of methods between labs and instruments, interpret validation data and ensure compliance with ICH, USP, and Ph. Eur. standards.

You will collaborate with QA, Regulatory Affairs, Manufacturing and Development to maintain data integrity and readiness for regulatory inspections, contributing to continuous quality improvements.

Qualifikationen

• Degree in Life Sciences/Natural Sciences or comparable training with relevant professional experience (e.g., chemistry, pharmacy, biology)
• Several years of analytical development, quality control or method validation in GMP
• Very good German and English language skills
• Strong IT skills (MS Office, LIMS, CDS, document management systems, instrument software)

Aufgaben

• Plan, lead and execute method development and validation per ICH, USP and Ph. Eur.
• Ensure test methods remain fit for purpose throughout lifecycle and support revalidation.
• Coordinate method transfers between internal and external labs and to new instruments.
• Interpret validation data for precision, accuracy, linearity and robustness; apply statistics to trends.
• Prepare, review and approve validation plans, reports, SOPs and work instructions; ensure ALCOA+ data integrity.
• Support regulatory inspections (EMA, FDA, Notified Bodies) and cross-functional teams.

Kenntnisse

Method Development

Validation in GMP Environment

Statistical Analysis

Regulatory Compliance

Data Integrity Management

Ausbildung

Life Sciences/Natural Sciences degree

Tools

MS Office

LIMS

CDS

Document Management Systems

Instrument Software

Jobbeschreibung

• In a central role, you will be responsible for the strategic planning, leadership and hands-on execution of method development and validation in accordance with ICH, USP and Ph. Eur.
• Throughout the entire lifecycle, you will ensure that existing test methods remain fit for purpose — from monitoring and optimization to revalidation.
• Scientific quality and regulatory compliance are the focus, ensuring that test methods meet the requirements of GMP, ICH and ISO at all times.
• You will reliably and purposefully coordinate method transfers between internal and external laboratories and the transfer to new instruments.
• You will interpret validation data with sound judgement and evaluate parameters such as precision, accuracy, linearity and robustness.
• You will apply statistical methods selectively to identify and assess trends and deviations at an early stage.
• You will prepare, review and approve validation plans, reports, SOPs and work instructions, ensuring a clear and traceable documentation basis.
• You will maintain constant oversight of data integrity requirements (ALCOA+) as well as GMP-compliant documentation and data storage.
• You will contribute your expertise during regulatory inspections (e.g., EMA, FDA, Notified Bodies) and support them confidently.
• In close collaboration with Quality Assurance, Regulatory Affairs, Manufacturing, Development and external partners, you will drive topics forward jointly.

Requirements

• Degree in Life Sciences/Natural Sciences (e.g., Chemistry, Pharmacy, Biology) or comparable scientific/technical training with further qualification 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 language skills
• Good IT skills (MS Office, LIMS, CDS, document management systems and instrument software)
• Team player

Core Competencies

Demonstrates expertise in method development and validation in compliance with ICH, USP, and Ph. Eur. standards, with a strong focus on scientific quality, regulatory compliance, and data integrity in a GMP-regulated environment.

Highest-signal resume keywords

• Method Development
• Validation in GMP Environment
• Statistical Analysis
• Regulatory Compliance
• Data Integrity Management

ATS Optimization Keywords

Hard Skills

• Analytical Development
• Quality Control
• Method Validation
• Statistical Methods
• Precision Evaluation
• Accuracy Evaluation
• Linearity Assessment
• Robustness Evaluation

Soft Skills

• Team Player
• Leadership

Industry Keywords

• GMP
• ICH
• USP
• Ph. Eur.
• ALCOA+
• EMA
• FDA
• Notified Bodies

Tools & Technologies

• MS Office
• LIMS
• CDS
• Document Management Systems
• Instrument Software