Site Head Quality (m/f/d)

About the Role and Responsibilities

EPM Scientific is collaborating with a prominent pharmaceutical manufacturer operating within strict GMP regulations to recruit a Site Head for Quality. This leadership position is crucial for managing Quality Assurance and Quality Control operations, ensuring adherence to compliance, sustaining product quality benchmarks, and fostering a robust culture of quality throughout the site.

• Lead and oversee all Quality Assurance and Quality Control functions on site, ensuring full compliance with EU-GMP standards and organizational quality protocols.
• Act as the main Quality liaison for the site, coordinating efforts with Operations, Technical, Regulatory, and Corporate Quality departments to meet business and compliance targets.
• Supervise product quality management across all stages, including testing, batch approval, and disposition decisions.
• Manage, develop, and mentor quality team members to promote responsibility, continual enhancement, and GMP best practices.
• Ensure the Quality Management System’s efficiency by managing processes such as deviation handling, CAPAs, change controls, investigations, risk assessments, and document maintenance.
• Lead audit preparations and inspection readiness for regulatory, customer, and internal examinations, addressing findings swiftly and effectively.
• Monitor quality performance through relevant KPIs, identifying and implementing improvements in operational and compliance aspects.
• Provide quality leadership support to manufacturing and laboratory teams in resolving compliance and product quality issues.
• Review and maintain quality policies, procedures, and related site documentation to meet both regulatory and company standards.
• Contribute to strategic quality projects aimed at enhancing quality culture and operational excellence throughout the site.

Candidate Requirements

• A bachelor's degree or higher in Pharmacy, Chemistry, Biology, Biotechnology, Engineering, Life Sciences, or a closely related scientific field.
• Extensive experience in Quality Assurance, Quality Control, or Quality Leadership roles within GMP-regulated pharmaceutical, biotechnology, or life sciences manufacturing settings.
• Proven leadership capabilities in managing and developing quality teams in a manufacturing environment.
• In-depth knowledge of EU-GMP regulations, quality management systems, and regulatory compliance.
• Hands-on experience managing deviations, CAPAs, change controls, investigations, risk management, and product release procedures.
• Demonstrated ability in supporting regulatory inspections and customer audits, maintaining continuous readiness for inspections.
• Excellent stakeholder engagement and communication skills, capable of influencing cross-functional teams and senior management.
• Successful track record of implementing quality improvements, performance management methods, and operational excellence initiatives.
• Strong problem-solving, decision-making, organizational skills, and accountability.
• Fluent proficiency in both German and English, spoken and written.