Job Title:
Senior Director, Quality Operations (EMEA)
Location:
UK Based - Hybrid Working Model
About the Role:
A global pharmaceutical company is seeking a Senior Director, Quality Operations to lead quality assurance and control across EMEA operations and API manufacturing. This is a critical leadership position, ensuring the highest standards of product safety, efficacy, and compliance throughout
the supply chain.
Key Responsibilities:
Strategic Leadership:
- Develop and execute the quality strategy for EMEA operations and API manufacturing to align with organizational goals.
- Lead initiatives to enhance quality systems, processes, and organizational culture.
Regulatory Compliance:
- Ensure adherence to GMP, FDA, EMA, ICH, and other international regulatory standards.
- Lead preparation for and management of regulatory authority inspections and audits.
Operational Oversight:
- Manage quality operations for API manufacturing, implementing robust quality assurance and control frameworks.
- Proactively identify and mitigate quality-related risks across the supply chain.
Team Leadership:
- Build, lead, and mentor a high-performing team of quality professionals across multiple locations.
- Drive a culture of accountability and excellence within the quality organization.
Cross-Functional Collaboration:
- Work closely with internal teams, including R&D, Supply Chain, Regulatory Affairs, and Manufacturing, to integrate quality standards throughout the product lifecycle.
- Collaborate with external partners, such as API suppliers and contract manufacturers, to maintain quality standards.
Performance Monitoring:
- Define and monitor key quality metrics to ensure continuous improvement.
- Provide regular quality performance updates and risk assessments to senior leadership.
Qualifications & Experience:
- 10+ years of progressive experience in quality assurance/control within pharmaceutical or biopharma industries.
- Strong knowledge of GMP regulations and quality systems, with a focus on API manufacturing and international operations.
- Proven experience leading teams across multiple geographies and managing complex quality challenges.
- Exceptional problem-solving skills and the ability to drive continuous improvement initiatives.
- Outstanding communication and stakeholder management abilities.
What's on Offer:
This role offers the opportunity to play a pivotal role in ensuring the quality and compliance of life-changing pharmaceutical products. You will have the chance to lead and shape the quality strategy for a globally impactful organisation.
How to Apply:
To express your interest in this confidential opportunity, please submit your CV and a cover letter outlining your experience and suitability for the role
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