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Quality Manager Pharma - Job Opportunity at Aktiv Personal-Service GmbH

Biberach an der Riß, Germany
Full-time/Part-time
Senior
Posted: March 27, 2025
On-site
EUR 65,000 - 85,000 annually based on Baden-Württemberg chemical industry tariffs and role seniority

Benefits

Comprehensive chemical industry tariff-based compensation
Performance bonuses and extra-tariff allowances
25-30 days annual vacation
Holiday and Christmas bonuses
Company-sponsored sports and wellness facilities access
Employee savings benefits program
Comprehensive medical screenings
Discounted event tickets and retail purchases
Professional development support

Key Responsibilities

Lead quality assurance for clinical trial inspections and audits with strategic oversight
Manage and develop quality documentation systems for clinical processes
Implement and monitor quality control measures with focus on continuous improvement
Provide expert consultation on GCP compliance and process optimization
Direct CAPA implementation and effectiveness monitoring
Guide team development through quality training initiatives

Requirements

Education

Advanced degree in Natural Sciences, Health Sciences, Clinical Research, or Pharmaceutical Science

Experience

Multiple years in Phase 1 Clinical Trials

Required Skills

GCP, AMG, MPG, GCP-V regulatory expertise ICH, FDA, EMA guidelines knowledge Quality management systems Employee training and development Fluent German and English Clinical research understanding Process improvement methodology Documentation management Regulatory compliance

Certifications

GCP certification preferred
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on early-phase clinical trials is driving demand for specialized quality management expertise in the pharmaceutical sector Growing regulatory complexity in EU pharmaceutical development is elevating the importance of quality management roles Digital transformation in clinical trial management is creating new demands for quality oversight expertise

Role Significance

Typically operates within a specialized quality team of 5-8 professionals in a clinical research environment
Senior position with strategic oversight of quality systems and significant influence on regulatory compliance outcomes

Key Projects

Phase 1 clinical trial quality management systems implementation Regulatory inspection preparation and management Quality system optimization and modernization initiatives Cross-functional process improvement programs

Success Factors

Deep understanding of evolving GCP requirements and ability to translate into practical quality systems Strong stakeholder management skills across clinical operations Ability to balance regulatory compliance with operational efficiency Forward-thinking approach to quality system modernization

Market Demand

High demand with growing emphasis on early-phase clinical trial expertise and increasing regulatory requirements in the EU pharmaceutical sector

Important Skills

Critical Skills

GCP and regulatory framework expertise is essential for ensuring compliance and trial validity Quality management system experience is crucial for process optimization Communication skills are vital for stakeholder management and team development

Beneficial Skills

Digital quality management systems knowledge Risk-based monitoring expertise Change management capabilities

Unique Aspects

Focus on early-phase clinical trials quality management
Combination of quality oversight and team development responsibilities
Strong integration with chemical industry benefits structure

Career Growth

2-4 years in role before advancement, depending on organizational growth and project success

Potential Next Roles

Senior Quality Director Head of Clinical Quality Global Quality Systems Leader Regulatory Affairs Director

Company Overview

Aktiv Personal-Service GmbH

Specialized staffing provider partnering with leading pharmaceutical research organizations in southern Germany

Well-established regional player in pharmaceutical and clinical research staffing
Strong presence in Baden-Württemberg's pharmaceutical cluster
Professional environment aligned with pharmaceutical industry standards, emphasizing quality and compliance
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