Consultant, Car-T Mock Inspection

Pharmatech Associates is seeking a Consultant to perform a mock inspection involving Car-T/Cell Therapy. This role is hybrid.

Project Responsibilities Include

• Providing input on standards and processes for ensuring compliance with regulatory requirements as well as corporate and departmental procedures
• Providing support for activities required in preparation for product launch
• Conducting mock inspection to assess company readiness for regulatory inspection including documentation, quality systems, and readiness of staff to engage with regulatory agency inspectors
• Managing responses to regulatory agency observations
• Managing inspection readiness activities
• Assessing compliance against regulatory filings and company processes for CAR-T medicinal products
• Evaluating risk management processes and documentation

Qualifications

• Collaborating with colleagues at all levels in the organization to identify potential compliance issues, implement risk management processes, participate in preventative and corrective action plans arising from audits and inspections, and work with management on long-term strategies
• Experience with global regulatory agency requirements, with focus on US FDA requirements
• Experience with mock inspection planning and response management
• Excellent interpersonal, problem solving and negotiation skills
• Bachelor’s degree with 10+ years’ experience in quality assurance

Pharmatech Associates, Inc. provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.