Job Description

Our client is seeking a highly motivated and experienced individual for a Director, Validation to provide leadership for all validation activities. This person 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.

This person must have experience working with oral-solid doses.

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

• Bachelor’s Degree in relatable field required.
• 12+ years’ experience in cGMP pharmaceutical manufacturing environment.
• Supervisory Experience: minimum of 6 years.
• Working knowledge of Quality Systems.
• Detailed knowledge of all aspects of validation.
• Detailed working knowledge of GMPs, FDA Aseptic Processing Guideline, EU “Orange Book”, GAMP, and ICH guidelines.
• Work with cross-functional leadership to provide resolutions to technical and/or personnel issues within projects and report issues to senior management and partners when they will have an impact on budget and/or timeline.
• Communication skills – must be able to effectively communicate department vision to staff members. Also, must be able to communicate laterally within the quality unit and externally.
• Solid organization and problem-solving skills.
• Strong leadership ability.

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