My client a pioneering biopharmaceutical company, poised to revolutionize rare disease treatment. As we advance into Phase 2 trials for our groundbreaking therapy, they are looking to recruit a senior QA specialist/manager to bolster their quality function. Reporting directly to the Senior Director Quality, you'll be instrumental in developing their quality processes as we gear up for clinical trials. This is initially a twelve-month fixed-term contract with potential for permanency post successful trials. The role is fully remote.

Key Responsibilities:

• Collaborate with GxP vendors to ensure compliance and address operational issues related to biological manufacture, QC testing, and product distribution.
• Support the Supplier Quality Management program through Quality Agreements and audits.
• Lead or participate in Quality Events including change controls, deviation investigations, CAPAs, and complaints.

Experience Required:

• Ideally degree qualified with 5-7 years of quality assurance experience in pharmaceutical or biopharmaceutical sectors.
• Strong background in supplier audit processes is essential.
• Experience in a startup environment is advantageous.
• QC experience is desirable.

The Next Step for you:

Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1662 9120

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