Head of Quality Strategy Post-Marketing (all genders)

Emd PM; Darmstadt; Vor Ort; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Head of Quality Strategy Post-Marketing to spearhead the development and execution of a global risk-based strategy. This pivotal role involves ensuring compliance with post-marketing processes while maintaining quality oversight across critical areas such as Pharmacovigilance and Regulatory Affairs. The ideal candidate will possess an advanced degree and over a decade of experience in quality assurance or regulatory compliance, demonstrating strong leadership in a matrix environment. Join a forward-thinking organization where your expertise will drive continuous quality improvements and foster a culture of excellence across global teams.

Qualifikationen

• 10+ years of experience in QA or relevant medical quality management.
• Strong knowledge of ICH GCP and GPV development principles.

Aufgaben

• Lead development of global risk-based quality oversight strategies.
• Provide expert guidance on GxP regulations and best practices.

Kenntnisse

Quality Assurance

Risk Management

Regulatory Compliance

Interpersonal Skills

Problem-Solving

Communication

Negotiation

Ausbildung

Advanced degree in pharmacy, medicine, or life sciences

Jobbeschreibung

Your role
As the Head of Quality Strategy Post-Marketing, you will lead the development and execution of a global risk-based strategy to ensure proactive quality oversight and compliance with post-marketing processes. You will monitor the execution and quality of these processes through dedicated KPIs and metrics, identifying signals, trends, risks, and gaps, while providing regular updates to the Head of Research & Development Quality and Risk Management (RDQRM).

You will be responsible for maintaining quality oversight across key areas, including Pharmacovigilance (PV), Medical Affairs, Regulatory Affairs, and Subsidiaries ensuring alignment with international and local health authority requirements and company standards. You will provide strategic direction for assigned due diligence projects and lead continuous quality improvements based on audits, inspections, trends, and root cause analyses.

Your role will include evaluating and modifying the RDQRM Post-Marketing strategy to meet the changing needs of the organization, regulatory environment, and industry best practices. You will collaborate closely with executive management and cross-functional business partners to identify compliance risks and drive issue resolution, ensuring the timely communication of critical quality issues, including potential misconduct or significant deviations.

In addition, you will provide expert guidance on GxP regulations and best practices to cross-functional teams, identify relevant governance bodies to foster a culture of quality, and oversee inspection readiness efforts. By creating a global network, you will ensure that quality oversight and related activities align with Medical, Regulatory, and Pharmacovigilance (PV) strategies across regions.

Who you are
• Advanced degree in a relevant scientific discipline (e.g., pharmacy, medicine, or life sciences).
• Minimum of 10 years of comprehensive experience in QA or relevant medical quality management, biomedical science, clinical development, or regulatory compliance.
• Proven ability to function autonomously at a senior level in a matrix model and team environment.
• Experience in a senior management role with accountability and strong interpersonal, communication, negotiation, influencing, and problem-solving skills, including the successful implementation of continuous improvement initiatives.
• Strong knowledge of ICH GCP and GPV development principles and Quality Assurance.
• Demonstrated ability to work in an international environment leading global quality functions.
• In-depth knowledge of applied risk management, including risk assessment, analysis, evaluation, reporting, communication, treatment, and continuous risk management.