Job Description:
This role is responsible for overseeing the Quality Strategy throughout the New Product Introduction (NPI) lifecycle, ensuring compliance with quality standards and client expectations. The ideal candidate will have a strong background in BioPharma industry, preferably in Validation, Quality or MSAT roles, and be familiar with EMA & FDA regulations; ICH and WHO guidelines.
Key Responsibilities:
* Lead QA oversight of all NPI, Technology Transfer and Product Continual Improvement teams to ensure compliance to SOPs, cGMP and CMC regulatory requirements.
* Act as a Quality advocate for consistency and harmonisation across specifications, analytical methods, and manufacturing processes.
* Be the technical lead between local QA, QC, QPs and the Client for product quality investigations, deviations, CAPAs and Master batch record review.
* Lead Quality role in the Technology Transfer for products to our facility.
* Execute a leadership role with Quality colleagues and other stakeholders on product quality investigations.
Requirements:
* Advanced degree in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or other related fields.
* At least 10 years relevant work experience in BioPharma industry.
* Familiarity with EMA & FDA regulations; ICH and WHO guidelines.
Benefits:
* Competitive salary and bonus structure.
* Parking facilities and sports & social club membership.
* VHI health insurance.