Director, Validation (Dayton)

Our client is seeking a highly motivated and experienced individual for a Director, Validation to provide leadership for all validation activities. The Director, Validation will be responsible for all clinical and commercial manufacturing support through facilities, equipment, filter, cleaning, and manufacturing process validation, support commissioning and qualifications of capital projects, computer systems qualification, and oversite of the entire validation program.

Responsibilities

• Development and oversight of corporate validation program to ensure compliance with cGMPs, FDA and EU guidelines. This includes guideline and policy development and enforcement.
• Responsible for preparation and management of corporate validation budget which includes clinical and commercial operations support and capital projects.
• Mentoring and developing staff which entails selecting and grooming department management team. Also, provide continuous assessment of team and implementation of various training programs to mitigate department weakness with respect to technical and compliance topics.
• Participate in corporate Capital Project Review Team and act as Quality representative.
• Develop and utilize department metrics as a tool for continuous improvement.
• Clearly define departmental roles and responsibilities with respect to internal and external boundaries.
• Provide annual reviews for departmental management team which includes establishment of individual goals and objectives.
• Review and approve departmental purchase requisitions.
• Translate corporate vision and goals into departmental goals and initiatives and provide oversight for success. Collaboration on site goals and policy creation along with assurance that tactical implementation of goals and policies are adhered to.
• Anticipate, analyze, and resolve issues within local Quality department as well as interdepartmentally. Create conditions and emphasize inclusion of all involved departments as necessary.

Qualifications