Site Head Quality (m/f/d)

Key Responsibilities:

• Provide overall leadership for the site's Quality Assurance and Quality Control functions, ensuring alignment with EU-GMP requirements and company quality standards.
• Serve as the primary Quality representative for the site, partnering with Operations, Technical, Regulatory, and Corporate Quality teams to support business and compliance objectives.
• Maintain oversight of product quality throughout the product lifecycle, including testing activities, batch disposition, and final approval or rejection decisions.
• Lead, develop, and mentor a team of quality professionals, fostering a culture of accountability, continuous improvement, and GMP excellence.
• Ensure the effectiveness of the site's Quality Management System (QMS), including deviation management, CAPAs, change controls, investigations, risk assessments, and document control processes.
• Drive inspection readiness and lead preparations for customer, internal, and regulatory audits, ensuring timely and effective responses to observations.
• Establish and monitor quality performance metrics and KPIs, identifying opportunities for operational and compliance improvements.
• Provide quality leadership and support to manufacturing and laboratory teams to address performance, compliance, and product quality challenges.
• Review, approve, and maintain quality policies, procedures, and site documentation to ensure compliance with regulatory and corporate requirements.
• Support strategic quality initiatives and continuous improvement projects that strengthen quality culture and operational excellence across the site.

Requirements:

• Bachelor's degree or higher in Pharmacy, Chemistry, Biology, Biotechnology, Engineering, Life Sciences, or a related scientific discipline.
• Significant experience within Quality Assurance, Quality Control, or Quality Leadership positions in GMP-regulated pharmaceutical, biotechnology, or life sciences environments.
• Proven leadership experience managing and developing quality teams within a manufacturing environment.
• Strong knowledge of EU-GMP regulations, quality systems, and regulatory compliance requirements.
• Demonstrated experience overseeing quality processes including deviations, CAPAs, change controls, investigations, risk management, and product release activities.
• Experience supporting regulatory inspections, customer audits, and maintaining a state of continuous inspection readiness.
• Strong stakeholder management and communication skills, with the ability to influence cross-functional teams and senior leadership.
• Track record of driving quality improvements, performance management initiatives, and operational excellence programs.
• Excellent problem-solving, decision-making, and organizational skills with a high level of accountability.
• Fluent German and English language skills, both written and spoken.