Key Responsibilities:
- Manage Quality Assurance qualification and validation activities
- Oversight of the Management of the site validation program as a SME (subject matter expert) Oversight of the master planning and management of the Site Validation Program as Subject Matter Expert (SME)
- Assure that execution of protocols and validation documents is performed using controlled change management processes and procedures
- Review and approve process validations, including equipment, cleaning, and computer systems
- Involvement with client and regulatory agency audits
- Handling discrepancy reports, coordination of protocol routing, as well as performing document generation
- Approving IQ, OQ, and PQ
- Communicating and coordinating with clients, systems owners, and project management regarding protocol activities and status reports
- Leading and facilitating risk based assessments and developing of sound risk based test strategies and plans, all while considering business and tech drivers
- Provide discrepancy reporting and investigational support
Key Requirements:
- Bachelors in a related field of study
- Experience in a Pharma/Biotech/Med Device Organization
- Commercial Manufacturing Experience
- Previous Validation Management Experience
- Experience with FDA and quality systems processes
- Good Manufacturing Practice (GMP) experience is required