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Senior Director, Head of Quality
1 month ago
Get AI-powered advice on this job and more exclusive features.
This range is provided by Meet Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay rangeDirect message the job poster from Meet Life Sciences
Lead Recruiter at Meet | Life Science RecruitmentWe are partnered with a commercial-stage biopharmaceutical company based in California that is focused on developing rare disease therapies. They are expanding to Europe and are seeking an expert Senior Director, Head of Quality to oversee quality functions, leading on compliance and quality systems as they build and execute on their launch strategy. This position will be hybrid, with 3 days onsite in Dublin, Ireland. We are open to relocators across the EU.
Job Responsibilities
- Lead and maintain the European Quality Management System (QMS) in compliance with EU/UK regulatory requirements.
- Secure and manage necessary WDA and MIA authorizations, ensuring GDP and GMP standards are upheld.
- Act as or support the Responsible Person (RP) for wholesale distribution activities.
- Oversee audits, inspections, deviations, CAPAs, and change control processes across EU operations.
- Collaborate with regulatory authorities, vendors, and cross-functional teams to ensure product quality and supply chain integrity.
Job Requirements
- Degree in Life Sciences, Pharmacy, or a related field; advanced degree (Master's/PhD) preferred.
- Minimum 10 years of experience in quality management, ideally in biopharma or rare diseases.
- Demonstrated success in building a European QMS from the ground up.
- Deep knowledge of EU regulatory requirements and quality standards across the product lifecycle.
- Excellent communication skills and ability to thrive in a fast-paced, cross-functional environment.
Contact:
For a confidential discussion, please reach out to Amit at amit.uma@meetlifesciences.com.
Seniority level- Seniority levelDirector
- Employment typeFull-time
- Job functionQuality Assurance
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