Site Quality Head

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Site Quality Head in Germany.

This role provides strategic and operational leadership for all site quality activities, ensuring compliance with global standards and fostering a culture of excellence. You will oversee quality assurance and control operations, guide cross-functional teams, and drive continuous improvement initiatives across manufacturing, laboratory, and validation processes. The position offers a high level of impact, as you will shape quality strategy, ensure regulatory compliance, and influence site performance metrics. You will also be responsible for developing talent, retaining high-performing team members, and promoting a culture of accountability and risk awareness. This is a senior leadership position with exposure to global projects, Health Authority interactions, and strategic decision-making in a dynamic pharmaceutical environment.

• Lead and provide oversight for strategic site quality initiatives and represent site quality in local and global cross-functional project teams.
• Ensure that all facilities, utilities, and equipment are designed, installed, and operated safely, effectively, and in compliance with applicable standards.
• Oversee planning, construction, commissioning, and validation activities (IQ, OQ, PQ) in compliance with cGMP.
• Escalate risks related to project timelines, budgets, and strategic planning, ensuring proactive mitigation.
• Manage product-critical quality issues, deviations, and out-of-specification events; define and monitor CAPAs, HA notifications, and compliance actions.
• Develop, monitor, and analyze Site Quality KPIs; establish and lead Site Quality Committees to ensure corrective and preventive actions are implemented.
• Drive accountability across site management, including execution of Site Quality Plans, risk assessments, and gap analyses.
• Recruit, develop, and retain talent within the quality team, fostering a high-performing and engaged workforce.

Requirements:

• BS or MSc in Life Sciences or related field.
• 10+ years of experience in GMP pharmaceutical manufacturing, including laboratory and aseptic operations.
• At least 3 years of combined experience in Quality Control and/or Quality Assurance.
• Proven track record in managing Quality Control operations and ensuring full compliance with global cGMP requirements.
• In-depth knowledge of cGMP regulations and successful experience managing Health Authority inspections.
• Strong project management skills, capable of handling multiple initiatives with moderate complexity and resources.
• Fluent in German and English, both written and spoken.
• Desirable: prior experience with Health Authority inspections and regulatory interactions.

Benefits:

• Competitive salary and annual bonus.
• Flexible working arrangements with options to work from home.
• Pension scheme and employee recognition programs.
• Comprehensive health and wellbeing programs supporting physical, mental, and social wellness.
• Employment with a top-tier, globally recognized employer.
• Unlimited opportunities for learning, development, and career growth.