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Senior Quality Assurance Manager
3 weeks ago
We are seeking a highly skilled and experienced leader to oversee the implementation of global quality standards at our site in Ireland.
Main Responsibilities:- Implementing quality standards across all systems, ensuring adherence to regulatory requirements.
- Providing strategic direction for QA-owned systems, manufacturing processes, and laboratory operations.
- Developing and maintaining quality procedures, policies, and systems related to data management and CSV.
The successful candidate will be responsible for ensuring the highest standards of product quality and compliance, overseeing system change control, deviation management, CAPA, and periodic review processes.
Requirements:- Bachelor's or advanced degree in Science, Engineering, Computer Science, Quality, or a related field.
- 10+ years of experience in leadership roles, with expertise in quality, compliance, data governance, and lab systems validation and quality assurance.
- Demonstrated knowledge of FDA, EMA, HPRA, MHRA, and other regulatory authorities for data integrity, CSV, QRM, and biopharmaceutical regulatory requirements.
A strong working knowledge of industry best practices and regulatory requirements is essential for this role. The ideal candidate will possess excellent communication and leadership skills, with the ability to work collaboratively with cross-functional teams.
