Associate Director Quality Assurance

2 giorni fa

Milan, Italia Barrington James A tempo pieno

We are seeking an experienced and forward-thinking Associate Director of Quality Assurance to join our growing pharmaceutical organisation and lead key Quality Operations across GMP manufacturing. In this role, you will oversee the continuous improvement of our Quality Management System, ensuring full compliance with global regulatory requirements (EU GMP, FDA, ICH, MHRA) and supporting the release of safe, effective, and high-quality products.

Key Responsibilities:

- Provide leadership to QA Operations, Quality Systems, and Compliance teams, ensuring alignment with corporate quality strategy.
- Oversee GMP quality activities including batch release, deviations, CAPA, change controls, risk assessments, and supplier qualification.
- Lead regulatory inspection readiness and act as a primary point of contact during audits (internal, external, and partner).
- Drive continuous improvement initiatives across QMS processes, digitalisation efforts, and cross-functional collaboration.
- Ensure robust management of documentation, training, validation, and manufacturing support processes.
- Partner with Manufacturing, QC, RA, Supply Chain, and R&D to support new product introductions and lifecycle management.
- Mentor, coach, and develop QA staff, fostering a culture of quality excellence and operational efficiency.

Qualifications & Experience:

- Degree in Life Sciences, Pharmacy, Biotechnology, or related field; advanced degree preferred.
- 8+ years of QA experience in the pharmaceutical industry, including leadership responsibility.
- Strong knowledge of GMP, GDP, ICH guidelines, Quality Systems, and regulatory expectations.
- Proven experience managing teams, regulatory audits, and complex quality operations.
- Excellent communication, decision-making, and stakeholder management skills.
- Demonstrated ability to lead continuous improvement and influence cross-functional teams.

What is Offered:

- Opportunity to lead transformative quality initiatives in a high-impact, high-growth environment.
- Competitive compensation, flexible working options, and strong professional development support.
- A mission-driven culture focused on patient safety, innovation, and operational excellence.

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