QA Manager, Deviations and CAPA

Just-Evotec Biologics is seeking a highly motivated QA Manager within the Quality Operations group that desires to be part of a team focused on improving worldwide access to Biotherapeutics! The role is responsible for overseeing the end-to-end management lifecycle for the Deviation, Nonconformance, and CAPA records and overseeing the programs from a quality perspective.

Responsibilities:

• Overall responsibility for deviation and CAPA management programs.
• Working with functional areas to determine actions to gather data and investigation content.
• Participating in client communication around deviations and investigations.
• Root cause analysis and classification, development of effective CAPA to address root causes.
• Preparing deviation records for review and approval.
• Monitoring and tracking performance metrics related to deviations and CAPAs.
• Participate in and help implement deviation and compliance improvement projects, including SOP revisions and Change Control management.
• Providing input on the development of personal performance goals.
• Train internal groups on relevant business processes.
• Perform tasks as requested by leadership to support Quality oversight activities.

Qualifications and Educational Requirements

• B.S. or M.S. degree, preferably in Engineering, Life Science, or an equivalent combination of education and experience in the Biopharmaceutical Industry.

• 5+ years of relevant experience in a Biopharmaceutical cGMP manufacturing or similar environment. Previous experience with writing and/or review of deviation and CAPA records preferred.
• Sound knowledge of cGMPs and Document Control guidelines set forth in ICH Q7 and Q10.
• Knowledgeable user of Root Cause Analysis tools (5 Why, Fishbone, etc.)
• Experience with GMP biologics manufacturing processes and equipment.
• Ability to communicate issues, ideas, and results clearly and professionally in a comprehensive and concise manner both verbally and in writing. Ability to explain complex issues and concepts with simplicity to a broad audience.
• Ability to guide staff and provide leadership across all levels of the organization.
• The ability to work both independently and collaboratively with scientific, operational, quality, and engineering staff across multiple disciplines in a fast-paced and dynamic environment.
• Significant experience navigating and managing various modules in a Quality Management System software suite.

• Strong focus on Quality and attention to detail.