Director of Quality
We are seeking an experienced and strategic Director of quality to lead our global manufacturing quality function and ensure full compliance with GMP, ISO standards, and regulatory expectations. This role offers the opportunity to shape quality systems across multiple sites while supporting innovation in pharmaceutical, biotech, and medical device manufacturing.
The Director will oversee enterprise-wide quality programs, including CAPA management, deviations, audits, supplier qualification, and compliance training. They will partner closely with Manufacturing, Technical Operations, and Supply Chain to embed a culture of quality, drive continuous improvement, and maintain inspection readiness at all times.
The ideal candidate brings a strong GMP background, proven leadership in regulated manufacturing environments, and the ability to influence and guide cross-functional teams. This is a senior, hands-on role that requires strategic vision, operational excellence, and a commitment to product integrity and regulatory compliance.
Responsibilities:
* Lead and manage the global quality function across multiple manufacturing sites.
* Ensure compliance with GMP, ISO standards, and global regulatory requirements.
* Drive inspection readiness for internal and external audits.
* Oversee CAPA, deviations, audit programs, and supplier qualification.
* Collaborate with cross-functional teams to implement quality initiatives and continuous improvement.
* Mentor, develop, and lead a high-performing quality team.
Qualifications:
* Proven experience in a senior quality role within pharmaceutical, biotech, or medical device manufacturing.
* Deep knowledge of GMP, ISO standards, and regulatory compliance (FDA, EMA, etc.).
* Strong leadership, strategic thinking, and operational execution skills.
* Excellent communication and stakeholder management abilities.
This is an outstanding opportunity to lead a global quality function and make a measurable impact on operational excellence and product integrity.