Associate Director of  Validations and Qualifications

Position Title: Associate Director of  Validations and Qualifications Department: Quality
Reports To: VP and GM of Operations Work Location: Decatur, Illinois

Position Summary:
The Associate Director of Validation will be an integral part in the re-opening of our Manufacturing facility in Decatur Illinois. Some of the key responsibilities will include but not be limited to: Authoring portions of regulatory submissions, developing and approving cGMP documents, leading all projects for the validation of equipment, processes, and products, project planning and execution, training, and tracking. This position will also be an FDA and Contract Client liaison in presentation of validation programs and documentation.

Essential Duties & Responsibilities:
• Responsible for authoring portions of regulatory submissions and defending the commissioning, design, and qualification of GMP, GLP equipment to regulatory agency representatives during inspections
• Develop and approve cGMP documents including, but not limited to, Master Validation Plans, Protocols, SOPs
• Leading and Managing projects for the validation equipment, processes, and products and to perform risk assessments to ensure compliance to all safety, quality, regulatory and operational requirements
• Review of equipment specification/design/procurement/installation and validation
• Project planning and execution including scheduling, task management, milestone planning and reporting
• Generation, review, and approval of project documentation (User Requirement Specifications, validation protocols, reports) and Standard Operating Procedures
• Support validation activities for project activities including review of validation documentation and attendance at validation activities (FAT, IQOQ, etc.)
• Employee will be required to develop an in-house training and competency courses for all grades of validation technicians
• Maintaining the validation tracking program, assessing the requirements for routine validation, revalidation and coordinating validation projects
• Actively support internal and contract research and development to scale and product transfer qualification and provide feedback internally
• FDA and Contract client liaison in presentation of validation programs and documentation

Position Requirements:
  • Advanced degree (Master of Science, PharmD, PhD)
  • Bachelor’s degree
  • Master’s degree a plus
  • 10-12 years’ experience of Validation experience in Pharmaceutical or Biopharmaceutical space
  • 5+ years’ experience in Validation Management experience at a senior level within a fast-paced pharmaceutical manufacturing environment
Specialized Training or Technical Knowledge Licenses, Certifications Needed:
• Must have direct experience with computer validation and determining computer validation (21CFR, Part 11) approach, including enterprise platforms systems
• Strong knowledge of MS Word, Excel, Outlook, and Power Point
• Proficiency with statistical and data software languages and packages
• Industry certification or credentials will be an asset
• Direct experience with FDA Inspectors, External Auditors

Job-Specific Competencies:
• Effective written and oral communication skills
• Strong organizational, planning and communication skills.
• Demonstrates exceptional time management skills.
• Using logic and reasoning to identify solutions to problems.
• Ability to multi-task, set priorities and meet strict deadlines.
• Ability to lead, motivate, coach, and teach others

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