Associate Director
2 weeks ago
**Role responsibilities**:
- Legal responsibility for QC for manufacturing and manufacturing directed release testing
- Assess and advise on release specifications and / or reject raw materials Evaluation of batch records to perform QP release of interim Drug Substance
- Approve and monitor internal and contract analysis testing
- Approve characterization and release testing on manufacturing specifications
- Ensure that out of specifications (OOS) and deviations are appropriately investigated and resolved
- Ensure all manufacturing directed testing and Product testing is performed accurately and appropriately.
- Review and approve assay validation protocols and reports
- Participate in continuous improvement projects (Local and Global)
- Prepare appropriate Standard Operating Procedures (SOP) and training modules when required and carry out the training.
- Be a member of on-site management team and attendance at leadership meetings (Local and Global)
**Who you are**:
- Degree, or equivalent, in relevant life science. Advance degree preferred
- Eligible to be a permanent Qualified Person for commercial and Investigational products
- Extensive hands-on experience in Quality Control
- Proven experience at a senior level leading a QC function in a life science GMP/FDA regulated environment, such as pharmaceutical and biopharmaceutical devices and diagnostics.
- Experience with common continuous improvement tools (e.g.six sigma).
- Extensive knowledge of EU/US GMP/GLP and related standards
- Technical experience of a wide range of biological testing techniques
- Proven ability to lead change through an organization
- Commercially aware
- Knowledge of Quality Risk Management.
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