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Software Validation Manager (m/w/d) pharmazeutisches Umfeld - Job Opportunity at expertum GmbH

Biberach an der Riß, Germany
Full-time
Senior
Posted: May 29, 2025
Hybrid
EUR 5,700 - 7,800 per month

Benefits

Comprehensive pension scheme through partnerships with Allianz and Nürnberger Versicherung providing long-term financial security above standard market offerings
Individualized professional development funding ensuring continuous skill advancement and career progression opportunities
Performance-based recognition program including birthday bonuses and referral incentives fostering employee engagement
Exclusive discount network across 600+ retail partners providing significant cost savings on everyday purchases
Premium safety equipment and occupational health services through dedicated medical center ensuring workplace wellbeing
Competitive salary structure aligned with IG Chemie Baden-Württemberg collective agreement plus industry-specific supplements

Key Responsibilities

Lead international project teams in validating computerized systems across pharmaceutical development operations, ensuring compliance with global regulatory standards and driving organizational excellence in CSV&C implementation
Architect and oversee comprehensive validation strategies for complex systems while ensuring adherence to GxP requirements and security protocols, directly impacting product development timelines and regulatory approval success
Develop innovative validation solutions and optimize existing applications to enhance operational efficiency and maintain competitive advantage in pharmaceutical development processes
Collaborate with global stakeholders to establish and maintain lifecycle documentation standards, ensuring seamless knowledge transfer and regulatory compliance across international operations
Design and implement comprehensive training programs and key-user concepts to maximize system adoption and operational efficiency while maintaining validation integrity

Requirements

Education

Master's degree (MBA, MSc) in natural sciences/technical field or completed technical/scientific vocational training with several years of professional experience

Experience

Several years of professional experience with validation requirements for computerized systems in regulated GxP environment, 21 CFR Part 11, and ISPE GAMP 5

Required Skills

Good understanding of SOPs/process landscape of corresponding business area Project management skills and leadership experience Good understanding of development data and data processing requirements Business-oriented mindset Strong resilience and stress tolerance Proven communication skills in interdisciplinary and international collaboration Strong presentation skills Fluent German and English skills in written and verbal communication

Certifications

GxP validation experience 21 CFR Part 11 knowledge ISPE GAMP 5 expertise
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented digital transformation driven by regulatory agencies' increasing emphasis on data integrity and computerized system validation, creating substantial demand for specialized validation managers who can navigate complex international regulatory landscapes while ensuring compliance across multiple jurisdictions. Pharmaceutical companies are investing heavily in advanced manufacturing technologies and digital solutions to accelerate drug development timelines, requiring validation professionals who can implement robust CSV frameworks that support both innovation and regulatory compliance in an increasingly competitive market environment. The convergence of artificial intelligence, machine learning, and traditional pharmaceutical processes is creating new validation challenges that require professionals with deep technical expertise and strategic thinking capabilities to ensure these emerging technologies meet stringent regulatory requirements while delivering business value.

Salary Evaluation

The offered salary range of EUR 5,700-7,800 monthly (approximately EUR 68,400-93,600 annually) is competitive for the German pharmaceutical market, particularly in Baden-Württemberg region. This compensation level reflects the specialized nature of CSV expertise and aligns well with industry standards for senior validation roles in regulated environments, considering the combination of leadership responsibilities and technical expertise required.

Role Significance

The position typically involves leading international, interdisciplinary teams of 5-15 validation specialists, quality assurance professionals, and technical experts across multiple geographic locations, requiring strong matrix management skills and cross-cultural leadership capabilities.
This is a senior-level position requiring substantial leadership capabilities and deep technical expertise in pharmaceutical validation. The role involves managing international teams and complex validation projects, indicating significant organizational responsibility and strategic impact on business operations and regulatory compliance.

Key Projects

Implementation of enterprise-wide CSV frameworks for new pharmaceutical manufacturing systems Validation of complex laboratory information management systems (LIMS) and electronic batch records Regulatory compliance projects for FDA, EMA, and other international health authority inspections Digital transformation initiatives involving cloud-based pharmaceutical development platforms Cross-functional validation projects supporting new chemical entity (NCE) development programs

Success Factors

Deep understanding of international pharmaceutical regulations combined with practical implementation experience enables successful navigation of complex compliance requirements while maintaining operational efficiency and supporting business objectives in highly regulated environments. Strong leadership and communication skills across diverse cultural and technical backgrounds facilitate effective team management and stakeholder engagement, ensuring project success in complex international pharmaceutical development environments. Strategic thinking capabilities that balance regulatory compliance requirements with business needs enable optimization of validation processes while maintaining rigorous quality standards and supporting accelerated product development timelines. Continuous learning mindset and adaptability to emerging technologies and evolving regulatory landscapes ensure long-term success in the rapidly changing pharmaceutical validation field.

Market Demand

High demand exists for experienced software validation managers in the pharmaceutical sector, driven by increasing regulatory complexity, digital transformation initiatives, and the critical need for CSV expertise in drug development processes. The specialized skill set combining technical validation knowledge with international project management capabilities makes this role particularly valuable in the current market.

Important Skills

Critical Skills

GxP validation expertise represents the foundation of pharmaceutical compliance and is absolutely essential for ensuring product safety, regulatory approval, and market access. This knowledge directly impacts patient safety and organizational reputation, making it the most valuable skill in pharmaceutical validation roles. International project management capabilities are crucial for success in global pharmaceutical organizations where validation projects span multiple countries, regulatory jurisdictions, and cultural contexts. The ability to coordinate complex international teams directly correlates with project success and career advancement potential. Technical systems knowledge combined with business acumen enables validation professionals to balance compliance requirements with operational efficiency, ensuring that validation activities support rather than hinder business objectives while maintaining rigorous quality standards.

Beneficial Skills

Emerging technology expertise in areas such as cloud computing, artificial intelligence, and advanced manufacturing systems provides competitive advantage as pharmaceutical companies increasingly adopt innovative technologies requiring specialized validation approaches. Regulatory strategy understanding beyond basic compliance requirements enables validation managers to contribute to organizational strategic planning and business development initiatives, positioning them for advancement into senior leadership roles. Change management and organizational development skills become increasingly valuable as pharmaceutical companies undergo digital transformation initiatives requiring both technical validation expertise and the ability to guide organizational culture change.

Unique Aspects

The role offers direct involvement in new chemical entity (NCE) development, providing exposure to cutting-edge pharmaceutical research and the opportunity to impact drug development from early stages through commercialization, representing significant professional development potential.
International scope combined with local German market presence creates unique opportunities for global career development while maintaining stability and deep industry connections within one of Europe's strongest pharmaceutical markets.
The position bridges technical validation expertise with business strategy, offering comprehensive exposure to pharmaceutical operations and potential for advancement into senior executive roles within the industry.
Integration with established pharmaceutical companies through staffing arrangement provides access to enterprise-level projects and resources while maintaining flexibility and diverse professional experiences.

Career Growth

Career progression to director-level positions typically occurs within 3-5 years for high-performing validation managers, with potential advancement to VP-level roles within 5-8 years depending on organizational growth, business impact, and continued professional development in regulatory and business strategy.

Potential Next Roles

Director of Quality Systems and Validation with expanded responsibility for enterprise-wide quality management and regulatory strategy Head of Digital Transformation in pharmaceutical operations, leading organization-wide technology adoption and validation initiatives Senior Consultant specializing in pharmaceutical validation, providing expertise to multiple organizations and regulatory agencies Vice President of Regulatory Affairs with broader responsibility for compliance strategy and regulatory submissions

Company Overview

expertum GmbH

expertum GmbH operates as a specialized staffing and recruitment firm focused on technical and pharmaceutical sectors, providing both temporary staffing solutions and permanent placement services. The company serves as an intermediary connecting skilled professionals with established pharmaceutical and chemical companies, particularly in the Baden-Württemberg region known for its strong industrial and pharmaceutical presence.

As a regional staffing specialist, expertum GmbH maintains strong relationships with major pharmaceutical and chemical companies in southern Germany, offering competitive positioning in the technical recruitment market through industry-specific expertise and deep understanding of regulatory requirements in highly specialized fields.
The placement in Biberach an der Riß positions professionals within one of Germany's most significant pharmaceutical clusters, home to major international pharmaceutical companies and offering excellent career development opportunities within a concentrated industry ecosystem that facilitates professional networking and career advancement.
The hybrid work model and emphasis on professional development suggest a progressive approach to employee engagement, balancing operational requirements with work-life balance considerations typical of modern pharmaceutical organizations seeking to attract and retain top talent in competitive technical fields.
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