Validation Director

To establish validation policy/strategy to manage projects relating to biopharmaceutical manufacturing equipment, critical computer systems, manufacturing processes and laboratory documentation and to ensure the validation deliverables meet the quality standards and requirements of company policies and FDA regulations.

Manage multiple projects to provide documented validation of equipment, control systems, CGMP utilities and manufacturing processes

• Establish philosophy, structure and scope in compliance with regulatory requirements through Validation Master Plans, policy and standard operating procedures

• Manage the activities of direct reports to accomplish scope of work of validation department

• Manage protocol and report development, execution and approval associated with commissioning and validation, cleaning validation and process validation

• Review and approve facility equipment and soft ware changes, evaluate and determine required validation testing

• Coordinate contract commissioning and validation services including contract review and approval

• Oversee the implementation of laboratory validation requirements

Coordinate the development, execution and approval Enhanced Design Reviews and Risk Assessments

• Reviews processes for application of Process Analytical Technology (PAT)

• Manage and monitor on-time closure of investigations and corrective action/preventive action items

• Determine training requirements for commissioning and validation for validation department, contractors, vendors and consultants and supervise the execution of required training

Possess excellent supervisory, interpersonal, leadership, project management skills

• Must possess confidence and be able to communicate with all levels of personnel and regulatory authorities

• Demonstrated ability to build, develop, lead and manage staff