Head of Quality / QP

Discover International; Leipzig; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A global healthcare solutions company is seeking a Quality Manager in Leipzig, Germany. You will define and execute a quality compliance strategy within a GMP-regulated environment and oversee management systems. The ideal candidate has a degree in a natural science, several years of leadership experience in a GMP context, and fluency in German and English. Strong knowledge of EU-GMP and regulatory requirements is essential. Competitive salary and career advancement opportunities are offered.

Qualifikationen

• Eligibility as Qualified Person according to §15 AMG.
• Experience in GMP-regulated pharmaceutical environment.
• Fluency in German and English.

Aufgaben

• Define and execute site-wide quality and compliance strategy.
• Establish and maintain GMP- and ISO-compliant management systems.
• Act as Qualified Person (QP) for batch certification.
• Serve as primary interface with regulatory authorities.

Kenntnisse

Leadership in GMP-regulated environments

Knowledge of EU-GMP

Excellent communication skills

Strategic mindset

Ausbildung

Degree in pharmacy, chemistry, or comparable natural science

Jobbeschreibung

We are partnered with a global healthcare solutions company focused on personalized medicine and pharmaceutical compounding support, providing high-quality ingredients, technologies, and services that enable customized patient care. The organization combines innovation, regulatory expertise, and international collaboration to support evolving healthcare needs worldwide.

Responsibilities

• Define and execute site-wide quality and compliance strategy within a GMP/GDP-regulated EU environment.
• Establish and maintain GMP-, GDP-, and ISO-compliant management systems (ISO 9001, 14001, 50001) and ensure continuous audit and inspection readiness.
• Act as Qualified Person (QP) in accordance with §15 AMG and EU-GMP Annex 16, performing batch certification and release decisions.
• Review batch documentation and evaluate deviations, OOS/OOT results, complaints, and changes to determine release or escalation.
• Serve as primary interface with regulatory authorities, auditors, and certification bodies, supporting inspections and licensing activities.
• Oversee CAPA, risk management, and quality governance, ensuring effective collaboration across QA, QC, and external partners.
• Support validation, data integrity, and oversight of outsourced quality activities.
• Lead and develop the quality organization while promoting a strong quality culture.

Requirements

• Degree in pharmacy, chemistry, or a comparable natural science discipline; eligibility as Qualified Person according to §15 AMG.
• Several years of leadership experience in a GMP-regulated pharmaceutical environment, including batch release responsibilities.
• Strong knowledge of EU-GMP (especially Annex 16), GDP, ISO management systems, and regulatory requirements.
• Experience interacting with regulatory authorities, audits, and inspections.
• Strategic mindset, strong decision-making skills, and high sense of responsibility.
• Excellent communication skills with fluency in German and English.