Senior Method Validation Manager – m/w/d

Minor Hotels Europe and Americas

Strategic Method Validation Manager responsible for planning and executing validations at Heraeus Medical. Focused on ensuring scientific quality and regulatory compliance in medical technology.

Posted 6/15/2026full-timeWehrheim • 🇩🇪 GermanySeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Benefits

Comp & perks

Exciting responsibilities – take them on with a high level of personal responsibility in an ambitious environment with excellent development opportunities
Attractive compensation – strong base salary according to the chemical industry collective agreement, annual one-off payments (holiday pay, 13th salary, future contribution) and extension of statutory long‑term care insurance with a supplementary care insurance
Financial additional benefits – support for private pension plans, life-phase account for paid leave (e.g., sabbatical, early retirement), discounts in many (online) shops, bike leasing
Regulated working hours – 37.5 hours per week, 1–2 days per week of remote work, time off in lieu for overtime, seniority leave, 30 days annual leave, special leave for special occasions
Health & well‑being – company medical service with comprehensive preventive examinations, social counseling and an in-house employee canteen with freshly prepared meals daily
Sustainability and social commitment – sustainability as part of the corporate strategy and targeted support of initiatives in the areas of education, family and science through the company’s own foundations

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Hard Skills & Tools

method developmentmethod validationstatistical methodsanalytical developmentquality controldata interpretationGMP complianceregulatory compliancedocumentationdata integrity

Soft Skills

leadershipstrategic planningteam playercollaborationcommunicationjudgmentorganizationproblem-solvingattention to detailadaptability