Head QA Operations(m/w/x)

Beschreibung

You will lead the QA Operations team to ensure GMP compliance across the site. By overseeing core quality systems and mentoring staff, you'll maintain inspection readiness and drive continuous improvement.

Anforderungen

• •Advanced degree in pharmacy, biochemistry, biotechnology, or related discipline
• •Minimum 8 years GMP-regulated environment and Quality Assurance experience
• •Several years managerial and people-leadership experience
• •Thorough knowledge of pharmaceutical cGMP requirements
• •Detailed knowledge of Quality Management System processes
• •Understanding of biopharmaceutical manufacturing and quality control
• •Experience with QA-relevant software systems or equivalent
• •Track record of successful audits and inspections
• •Strong leadership and people-management skills
• •Strong organizational and prioritization skills
• •Strong communication and stakeholder-management skills
• •Fluent English and preferred German language skills

Aufgaben

• •Lead the QA Operations and Validation teams
• •Oversee GMP compliance for manufacturing and engineering
• •Manage deviations, CAPAs, and change control processes
• •Review and approve essential GMP documentation and SOPs
• •Ensure timely and consistent performance of risk assessments
• •Coordinate equipment qualifications and process validations
• •Support regulatory inspections and customer audits
• •Act as the primary quality contact for customers
• •Mentor and develop associates within the QA department
• •Collaborate cross-functionally with supply chain and IT
• •Drive continuous improvement for quality-related processes
• •Escalate quality issues through structured decision-making

Tools & Technologien

Benefits