Senior Quality Assurance Operations Director
hace 3 semanas
Company Overview
Empresa Reconocida is a renowned organization dedicated to delivering innovative solutions. Our commitment to excellence drives us to seek talented professionals who share our passion for quality.
Salary
We offer an estimated annual salary of $120,000, commensurate with experience and qualifications.
Job Description
The Senior Quality Assurance Operations Director will be responsible for providing QA oversight and support for contract manufacturing and testing facilities as well as internal functions. This role requires ensuring compliance with internal policies and procedures and specifications, regulatory requirements, and supporting quality improvement initiatives. The incumbent will provide person-in-plant QA presence at contract manufacturing organization (CMO) sites for oversight of drug substance and drug product fill-finish activities.
Responsibilities
- Provide person-in-plant QA presence at CMO sites to ensure adherence to approved policies, SOPs, quality agreements, batch records, regulations, and timely documentation, notification/escalation, and resolution of any issues and nonconformities.
- Review and approve cGMP documentation, including SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls.
- Support quality investigations and manage CAPA for CMO activities.
- Review and coordinate approval of all changes made to the manufacturing, testing, and control processes initiated by CMOs and Contract Laboratory Organizations (CLOs).
- Review batch records, testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met, conducted in accordance with regulatory filings, regulatory requirements, and internal policies and procedures.
Requirements
To be considered for this role, you must possess a Bachelor's degree in Sciences or Engineering and have 5-8 years of applied Quality industry experience. You should have working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in hosting and facilitating successful regulatory inspections.
Benefits
We offer a comprehensive benefits package, including health insurance, retirement savings plan, and paid time off.
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