Quality Assurance Leader Germany PDx - Pharmaceutical Entrepreneur and Marketing Authorisation Holder (f/m/d)

Job Description Summary

The Quality Assurance Leader Germany PDx provides quality leadership and independent quality governance for the German Pharmaceutical Entrepreneur (Pharmazeutischer Unternehmer) and Marketing Authorisation Holder (MAH) activities.
The role is accountable for establishing a robust quality governance framework that ensures compliance with German and EU regulatory requirements, corporate quality standards, and MAH obligations. Acting as the senior quality authority for the German PDx business, the position provides independent quality judgement, drives risk-based decision-making, and influences business strategy to protect patients, product quality, regulatory compliance, and business continuity.
The role serves as the primary quality partner to senior leadership and works closely with Regulatory Affairs, Pharmacovigilance, Medical Affairs, Supply Chain, Commercial teams, manufacturing sites, and external service providers to ensure quality considerations are effectively embedded across the product lifecycle.

At GE HealthCare, our machines, our software, our solutions, our services, and our people make a genuine difference to medical professionals and patients all over the world. That’s because we never lose sight of what healthcare really needs—the human touch.

Job Description

Key Responsibilities:

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.

Qualifications:

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

Strong knowledge of:

• 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

What we offer:

If you are interested in learning more we are looking forward to your online-application!

Don't meet all the requirements? We are aware that there is almost never a perfect profile. You can learn (almost) anything as long as you are interested and enjoy new topics and challenges. In short: we look forward to receiving your application, even if you do not yet meet the requirements 100%!

About us

GE HealthCare is a leading global medical technology and digital solutions innovator with over 100 years of healthcare industry experience and around 50,000 employees globally. We enable clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by our Edison intelligence platform. We operate at the center of an ecosystem working toward precision health - digitizing healthcare, helping drive productivity and improving outcomes for patients, providers, health systems and researchers around the world.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

GE HealthCare - Creating a world where healthcare has no limits

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Additional Information