Overview:
A clinical-stage biopharmaceutical company seeks a Senior Manager, specifically a Qualified Person (QP), to oversee quality assurance for its UK operations. This role involves acting as the designated QP in accordance with regulatory standards and ensuring compliance with the UK Good Manufacturing Practice (GMP). The Senior Manager will play a pivotal role in releasing and monitoring the quality of batches, adhering to marketing authorizations, clinical trial authorizations, and relevant regulatory requirements.
Key Responsibilities:
• Collaborate with the MHRA Agency for Medicinal Products on quality-related matters.
• Independently decide on batch release or rejection, ensuring compliance with UK GMP and GDP, marketing authorizations, and other relevant regulations.
• Ensure thorough testing of finished medicinal product batches to meet quality requirements.
• Supervise handling, distribution, and compliance with regulatory requirements and internal procedures.
• Support identification and remediation of gaps and risks in the quality management system.
• Manage audits, inspections, and Contract Service Providers (CSP) audit program.
• Cross-functional collaboration with various departments for project support.
• Participate in Quality Management Reviews (QMR) and contribute to regional activities.
• Stay updated on regulatory developments impacting the company's activities.
Education, Registration & Certification:
• Degree in Life Sciences
• QP registration in the UK
• Membership in a professional body recognized by the MHRA
Experience:
• 8+ years of industry experience
Skills, Knowledge & Abilities:
• Experience in GMP and GDP activities
• Knowledge of medicinal product legislation and corresponding guidance
• Familiarity with industry regulations and compliance standards
