Senior Manager, Bio-Tox Analytical QA

We are currently hiring a Senior Manager, Bio-Tox Analytical QA, to join our team for a 23-month contract. The Senior Manager, Bio-Tox Analytical QA is responsible for developing and overseeing a robust Quality Assurance strategy focused on the transfer of New Product Introduction (NPI) QC methods to manufacturing sites and Third-Party Laboratories. This role supports the Test Method Gate Review process, reference standard and critical reagent controls, and ensures the quality perspective is built into product development early. Covering mAbs, ADCs, Neurotoxins, Gene Therapy, and emerging biological entities across Immunology, Oncology, Neuroscience, Eyecare, and Aesthetics, this position acts as a quality technical lead supporting strategic research, compliance, and collaboration across multidisciplinary teams.

Responsibilities:

• Review and approve Drug Substance and Drug Product specifications for Biologics, Neurotoxins, and Gene Therapy products.
• Support QA/QC business units by delivering program strategies, managing projects, and overseeing unit operations in line with business objectives.
• Provide quality technical leadership in multidisciplinary settings to keep activities on track with timelines and business needs.
• Support and execute development, manufacturing, and customer-centric plans.
• Develop, negotiate, and finalise project timelines and cost estimates to fulfil business and customer requirements.
• Apply advanced scientific expertise to manage and support complex, multi-disciplinary projects.
• Use advanced technical writing skills to develop protocols and reports for product registration and business needs.
• Oversee processes and procedures to ensure product quality and regulatory compliance.
• Establish and enforce quality system procedures, interfacing across development, operations, quality, compliance, and regulatory functions.