QA Officer - Dev & Preclinical

Job Summary

Product Development Quality (PDQ) Good Manufacturing Practice (GMP) serves as the Quality Assurance Unit overseeing manufacture, testing and distribution of clinical supplies (investigational products) to assure quality and compliance with GMP and other applicable regulations and internal procedures.

Key responsibilities include drug product batch disposition (release/reject decision), Investigation Medicinal Product Certification and release by the External Manufacturing Quality, and audit of internal GMP systems/processes and suppliers/third party contractors, as well as assist stakeholders with regulatory advice and preparation for and management of regulatory agency inspections.

• Serves as Project Manager for prioritizing and alignment of external Qualified Person (QP) release of clinical supplies at Contract Manufacturing Organisations (CMOs).
• Partner with Regulatory Affairs and Global Clinical Supply Chain to ensure on-time delivery of Health Authority approvals for release of clinical supplies (as applicable).

Desired Characteristics:

• Ability to understand the needs of the business and commitment to deliver efficiency
• Able to collaborate across multiple teams
• Excellent communication skills
• Innovative and inquisitive nature to ask questions
• Ability to learn new tools and processes
• Excellent organisation and time management skills

• Project Manage/support the External QP release process.
• Co-ordinate/align on all required documentation.
• Triage/answer any QP related queries.
• Liaise with Trials Supplies Management (TSM), Trial Managers (TM), Regulatory CMC QA, Regulatory Affairs, and Product Development Quality.
• Identify dependencies, evaluate risks, and communicate status to appropriate levels of management and stakeholders across the business.
• Ensure project deliverables and schedules are met, adhere to established standards, which are managed in alignment with BMS Project Management best practices across their assigned projects.
• Proactively remove obstacles to drive assigned project’s momentum and progress
• Plan and engage necessary resources across the enterprise to ensure successful completion of assigned projects.

• Degree qualified or equivalent experience required.
• Project Management experience is essential.
• Previous Pharmaceutical Quality experience is desired/preferred.

Please note: this is a 12 month contract

#4663389 - Jack Martin