What You'll Do:
Lot Disposition Oversight:
- Review, evaluate, and approve all batch records, analytical testing data, and supporting quality documentation prior to lot release.
- Ensure all manufacturing and testing activities are performed in compliance with cGMP and applicable regulatory requirements.
- Oversee lot disposition processes for materials produced internally and by CMOs.
Data Review and Approval:
- Review and assess data generated by CMOs, including in-process and release testing results.
- Evaluate data generated by CTLs and in-house testing to verify compliance with specifications and regulatory expectations.
- Confirm resolution of deviations, investigations, and change controls prior to lot disposition.
- Review stability data, including test records, interim reports, and final stability reports, for accuracy, completeness and compliance
Compliance and Continuous Improvement:
- Ensure timely completion of lot disposition activities to meet clinical and commercial supply timelines.
- Identify process gaps and drive continuous improvement initiatives in quality systems related to lot disposition.
- Support internal and external audits related to lot disposition processes.
Cross-Functional Collaboration:
- Partner with Manufacturing, QC, Supply Chain, and Regulatory Affairs and Process and Assay Development as required to address quality issues impacting lot disposition.
- Provide guidance to internal and external stakeholders on quality standards and regulatory compliance.
About You:
- Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or equivalent experience.
- Minimum 5 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or related regulated industry, including experience with lot disposition.
- Experience working with CMOs and CTLs in a cGMP environment preferred.
- Strong understanding of cGMP, ICH guidelines, and applicable regulatory requirements.
- Proficient in reviewing manufacturing batch records, analytical data, and quality documentation.
- Excellent attention to detail and ability to make sound quality decisions.
- Strong organizational, problem-solving, and communication skills.
- Ability to work independently and in a cross-functional team environment.
- Proficiency with electronic quality management systems (e.g., MasterControl) is an asset.
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