Quality Assurance Leader (m/f/d)

Your Profile:

Education
• Degree in Pharmacy, Chemistry, Biology, Life Sciences, or other relevant scientific discipline.
  
• Advanced degree is desirable.

Experience
• Several years of relevant professional experience of pharmaceutical quality.
  
• Previous role as a Qualified Person (QP) and/or Responsible Person (RP) with MAH experience is strongly preferred.
  
• Demonstrated expertise in:
  • GMP and GDP compliance
    
  • Quality governance and quality systems
    
  • Regulatory inspections and audits
    
  • MAH and Pharmaceutical Entrepreneur operations
    
  • Quality risk management
    
  • Supplier and outsourced activity oversight
• Proven leadership experience within a regulated pharmaceutical environment.

Technical Knowledge
• EU GMP requirements
  
• EU GDP Guidelines
  
• German Arzneimittelgesetz (AMG) and associated regulations
  
• MAH and Pharmaceutical Entrepreneur obligations
  
• Inspection and audit management
  
• Product complaint, defect, and recall management
  
• Quality risk management principles and methodologies

Language
• Fluency in German and English languages is required

Your Tasks:

Quality Leadership & Governance
• Define and implement the quality strategy for the German PDx business, aligned with regional and global quality objectives.
  
• Act as the senior quality representative for the German Pharmaceutical Entrepreneur and MAH organisation.
  
• Establish and maintain governance processes that enable the identification, assessment, escalation, and mitigation of quality and compliance risks.
  
• Drive a culture of quality, integrity, accountability, continuous improvement, and risk-based decision-making across the organisation.
  
• Advise senior management on emerging quality, regulatory, and compliance risks and opportunities.

Quality Governance & Compliance Oversight
• Ensure quality governance arrangements are effective and support compliance with applicable MAH, Pharmaceutical Entrepreneur, GMP, GDP, and regulatory requirements.
  
• Monitor the effectiveness of quality systems through quality metrics, trend analysis, management review, and risk-based oversight.
  
• Ensure appropriate governance and escalation of significant quality events, compliance issues, and quality risks.
  
• Assess emerging regulatory requirements and oversee implementation of appropriate actions to maintain compliance.

Pharmaceutical Entrepreneur & MAH Oversight
• Provide quality leadership for the fulfilment of quality-related Pharmaceutical Entrepreneur and MAH obligations in Germany.
  
• Collaborate with Regulatory Affairs, the Information Officer (§74a AMG), Qualified Persons, and external partners to ensure products remain compliant throughout their lifecycle.
  
• Ensure appropriate quality oversight of product launches, variations, transfers, discontinuations, market actions, and recall activities.
  
• Support effective management of product quality issues, market complaints, defect investigations, and product recalls.

Inspection, Audit & Regulatory Engagement
• Lead quality inspection readiness and represent the organisation during regulatory authority inspections, corporate audits, partner audits, and external assessments.
  
• Provide strategic leadership in the management of inspection and audit observations.
  
• Ensure corrective and preventive actions are effective, sustainable, and appropriately monitored through governance processes.
  
• Serve as a trusted quality authority during significant regulatory interactions and escalations.

Quality Risk Management
• Ensure quality risks are identified, assessed, controlled, communicated, and reviewed using established risk management methodologies.
  
• Provide independent quality assessment and recommendations for significant business initiatives, product-related decisions, and compliance matters.
  
• Escalate critical risks and emerging compliance concerns to appropriate governance bodies and senior leadership.

Third-Party Quality Oversight
• Ensure robust quality oversight of contract manufacturers and other GxP service providers.
  
• Ensure supplier qualification, monitoring, and performance management processes effectively support regulatory compliance and product quality.

Stakeholder Leadership & Organisational Influence
• Build effective partnerships across Quality, Regulatory Affairs, Pharmacovigilance, Medical Affairs, Supply Chain, Commercial Operations, and Manufacturing.
  
• Lead quality initiatives that strengthen compliance capability, operational effectiveness, and organisational performance.

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