Quality Inspection Readiness Manager (v390)

Job Profile Summary

· The Quality Inspection Readiness Manager, is responsible to support real time inspection readiness activities within CMC Quality.

· The Manager will utilize their technical expertise to optimize interdisciplinary understanding and synergy with the group and integrate activities with other departments to shape a cohesive environment.

• In addition, this role supports the Product Complaint team and assists with triaging, investigating and processing Product Complaints.

· This role includes partnering with various internal and external cross-functional teams including Contract Manufacturing Organizations, Our client’s Manufacturing Center, Technical Operations, Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support and others within Quality Assurance.

Job Description & General Summary:

· The Quality Inspection Readiness Manager, is responsible to support real time inspection readiness activities within CMC Quality.

· The Manager will utilize their technical expertise to optimize interdisciplinary understanding and synergy with the group and integrate activities with other departments to shape a cohesive environment.

· In addition, this role supports the Product Complaint team and assists with triaging, investigating and processing Product Complaints.

· This role includes partnering with various internal and external cross-functional teams including Contract Manufacturing Organizations, Our client Manufacturing Center, Technical Operations, Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support and others within Quality Assurance.

Key Duties and Responsibilities:

*** The position is responsible to ensure the successful execution, but is not limited to the following:

• Management of vendor certificates and declarations to support GMP/GDP activities.
• Work with regional regulatory representatives to create/maintain schedule to track GMP renewals
• Develop and maintain tool to track certificates and declarations, including GMP/GDP vendor certificates on-hand and the rationale for declarations and health authority acceptance
• Manage incoming requests for certificates and declarations and work with cross-functional team to complete request.
• Provide cross-functional support and guidance to stakeholders.
• Inspection Management support in collaboration with AIM; Assist with GMP Quality Leadership Team Assist with GMP Quality Leadership Team
• Provide back room support for GMP/ GDP inspections.
• Coordinate preparation activities with SMEs
• Lead and assist with additional compliance team projects as needed.
• Real-time Inspection Readiness Product Complaints

Knowledge and Skills:

• Project Management Skills
• Understanding of GMP/GDPs and applicable guidelines/guidance (e.g., ICH, USP, etc.) or other industry best practices (e.g., ISPE, WHO, etc.)
• Excellent technical writing, presentation and communication skills.
• Experience conducting investigations, performing Root Cause Analysis and identifying CAPA
• Candidate must have experience in a Quality Assurance role supporting or relevant experience.

Education and Experience:

• Master’s degree and 5 years of relevant work experience, or
• Bachelor’s degree in a scientific or allied health field and 10 years of relevant work experience, or relevant comparable background
• Master’s degree and 5 years of relevant work experience, or
• Bachelor’s degree in a scientific or allied health field and 10 years of relevant work experience, or relevant comparable background
• Job Posting Description