- Provide quality oversight during the transfer of analytical methods.
- Oversee the development, verification, qualification, and validation of analytical methods by reviewing protocols, exceptions, and reports.
- Ensure adherence to FDA, USP, ICH, and internal regulatory policies for analytical method qualification and validation.
- Independently coordinate with internal departments and external CMOs / CTLs to facilitate project execution.
- Apply risk management principles to qualification and remediation efforts.
- Provide regular updates and reports to management on project status.
- Perform other related tasks as assigned.
Education and Skills Requirements :
- Bachelor's degree in a science-related field, with 8-12 years of relevant experience, preferably in biopharmaceutical or pharmaceutical industries.
- Direct experience with analytical method qualification and validation using FDA, USP, and ICH guidance.
- Hands-on experience with method development, qualification, and validation for clinical and commercial in-process and release testing.
- Strong understanding of GMP principles, concepts, and global validation standards.
- Knowledge of biologics / gene therapy processes is desirable.
- Ability to address complex quality issues with innovative and effective solutions.
- Familiarity with industry best practices and current trends in quality validation.
- Excellent verbal, written, and interpersonal communication skills.
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