Head QA Operations(m/w/x)

Beschreibung

You will lead the QA Operations team at a German CDMO site, ensuring GMP compliance and inspection readiness while acting as a key quality partner for both internal stakeholders and global customers.

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
• •Proven track record of successful audits and inspections
• •Very strong leadership and people-management skills
• •Very strong organizational and prioritization skills
• •Very strong communication and stakeholder-management skills
• •Fluency in English and preferred German skills

Aufgaben

• •Lead and grow the QA Operations organization
• •Provide technical and people leadership to teams
• •Drive excellence in core QMS processes
• •Manage deviations, CAPAs, and change controls
• •Oversee manufacturing, engineering, and supply chain compliance
• •Review and approve SOPs and documentation
• •Ensure constant inspection readiness for all processes
• •Manage risk assessments, qualifications, and validations
• •Represent the company during regulatory and customer audits
• •Conduct internal audits and self-inspections
• •Act as the primary quality contact for customers
• •Identify opportunities to strengthen site quality performance
• •Collaborate cross-functionally to achieve shared quality goals
• •Coach and mentor team members to build capabilities
• •Escalate and resolve quality-related issues promptly
• •Contribute to site-wide and cross-functional projects

Tools & Technologien

Benefits