Validation Manager - (US-MA-Confidential )

Minimum Education: Bachelors
Job Type: Full Time
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MISSION STATEMENT:
Responsible for the overall management of the QA Validation function to include supervision of exempt and non-exempt validation staff and management of site validation programs to ensure compliance to current industry and internal standards. Provide strong technical guidance to staff on current validation industry standards.

RESPONSIBILITIES:
• Validation of manufacturing processes, cleaning and sterilization processes, equipment & utilities and computer systems.
• Ensure all validation processes are in a state of compliance and all staff and processes are optimized.
• Provide expertise and management guidance for the Validation function to meet its goals and objectives.
• Responsible for day to day management of the Validation department, including department and capital budgeting, technical development/training, supervision of validation staff, validation scheduling, and resource utilization planning.
• Manage and review validation processes and procedures and implements changes and/or improvements to meet appropriate regulatory requirements, internal policies and current industry practices.
• Actively represents Validation on project teams with respect to the interpretation and application of regulatory requirements concerning validation.
• Manage validation contractors as needed.
• Maintain accountability for timely delivery of functional area objectives.
• Interact with senior management to report on department progress to meet goals and objectives.

EXPERIENCE:
• B.S. (M.S. or M.B.A. preferred) in a scientific or engineering discipline
• 10+ years relevant experience executing, developing, or administrating validation programs in cGMP biopharmaceutical environments is required.
• 5+ years previous management experience is required.
• Strong management experience, including direct oversight and scheduling of staff and validation activities.