Validation Manager - (US-MA-Worcester - 01655)

Compensation: $80K - $95K / Year
Minimum Education: None
Jobcode: 178924-JJ
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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. • Expert knowledge of facilities systems, cleaning and process validation from a diverse compliance background in cGMP manufacturing. • Experience with computerized system validation desirable. • Excellent interpersonal effectiveness and written & verbal communications skills. • Must possess in-depth knowledge of cGMP including ICH Q7A and 21 CFR.