Senior Method Validation Manager – m/f/d

Minor Hotels Europe and Americas

Senior Method Validation Manager leading method validation strategies and ensuring compliance with industry standards at Heraeus Medical. Engaging in quality assurance and collaboration across departments for optimal patient outcomes.

Posted 7/22/2026full-timeWehrheim • 🇩🇪 GermanySeniorWebsite

Core Competencies

Role fit

Core Competencies

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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 DevelopmentValidation in GMP EnvironmentStatistical AnalysisRegulatory ComplianceData Integrity Management

ATS Keywords

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Hard Skills

Analytical DevelopmentQuality ControlMethod ValidationStatistical MethodsPrecision EvaluationAccuracy EvaluationLinearity AssessmentRobustness Evaluation

Soft Skills

Team PlayerLeadership

Tools & Technologies

MS OfficeLIMSCDSDocument Management SystemsInstrument Software

Industry Keywords

GMPICHUSPPh. Eur.ALCOA+EMAFDANotified Bodies

About the role

Key responsibilities & impact

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

What you’ll need

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

Benefits

Comp & perks

Exciting responsibilities — take them on with a high degree of personal responsibility in an ambitious environment with excellent development opportunities
Attractive compensation — competitive base salary according to the chemical industry collective agreement, annual one-off payments (holiday pay, 13th salary under the collective agreement, Zukunftsbetrag/future allowance) as well as extension of statutory long-term care insurance with supplemental care insurance
Financial extras — support for private pension provision, life-phase account for paid leave (e.g., sabbatical, early retirement), discounts in many (online) shops, bicycle leasing
Structured working hours — 37.5 hours per week, 1–2 days per week mobile work, time off in lieu for overtime, senior leave, 30 days annual vacation, special leave for important occasions
Health & well-being — occupational health service with comprehensive preventive medical check-ups, social counselling and an in-house staff canteen with freshly prepared meals daily
Sustainability and social engagement — sustainability as part of the company strategy and targeted support for initiatives in the areas of education, family and science through company foundations