We are looking for a Global Quality Officer (m/f/d) for one of our clients.
Position Summary
The Global Quality Officer is responsible for the global quality strategy and for ensuring the highest standards of quality and compliance across all sites. Reporting directly to the executive leadership team, this role drives sustainable quality excellence within a highly regulated, international environment.
The Global Quality Officer will lead the ongoing development of the company’s quality framework and ensure full compliance with global GMP, GDP, and regulatory requirements, while fostering continuous improvement across the organization.
Key Responsibilities
Global Quality Strategy & Governance
- Define and implement a company-wide quality strategy
- Establish and further develop a harmonized global Quality Management System (QMS)
- Ensure compliance with international regulatory standards (e.g., EMA, FDA, ICH)
Operational Quality Leadership
- Lead the global quality organization (QA, QC, Compliance, Validation)
- Oversee preparation for and management of regulatory and customer inspections
- Ensure product quality across the entire value chain (API, drug product, and potentially biologics)
Compliance & Risk Management
- Implement a proactive quality and risk management approach
- Monitor, assess, and escalate critical quality events (deviations, CAPAs, OOS)
- Ensure data integrity and ongoing regulatory compliance
Culture & Transformation
- Promote a strong company-wide quality culture (“Quality Mindset”)
- Drive organizational, process, and systems improvements, including digital transformation initiatives
- Collaborate closely with Operations, R&D, Supply Chain, and Commercial teams
Stakeholder Management
- Act as the primary contact for global regulatory authorities and key customers
- Communicate effectively at executive level (Board, investors, partners)
- Support Business Development through quality expertise (e.g., audits, due diligence)
Profile
Qualifications & Experience
- Degree in Pharmacy, Chemistry, Biotechnology, or a related field (PhD preferred)
- Extensive leadership experience in global quality roles within the pharmaceutical industry
- Deep knowledge of GMP regulations (FDA, EMA, ICH) and inspection readiness
- Experience in CDMO, API, or complex manufacturing environments is a strong advantage
Leadership & Personal Attributes
- Proven track record in building and transforming global quality organizations
- Strategic mindset combined with strong execution capabilities
- Excellent communication skills and ability to influence at executive level
- Strong intercultural competence and experience in global organizations