The Role: Reporting to the Senior Manager, Quality Assurance (QA) Operations - Team Lead for the International Organization, the Manager QA Operations will be responsible for providing QA oversight and support for contract manufacturing and testing facilities as well as internal functions to ensure compliance with internal policies and procedures and specifications, regulatory requirements.
The Manager QA Operations will support quality improvement initiatives and ensure robust processes and systems are implemented across Moderna's international operations.
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 and support review and approval of all cGMP documentation including policies/SOPs, testing data, method validation protocols/reports, equipment and process validation lifecycle documentation, batch records, deviations, CAPA, and Change Controls.
The incumbent will be an integral partner to Moderna's innovative technology platform as we continue to integrate automation and digital technology into everything we do.
Here's What You'll Do: Provide person in plant QA presence at contract manufacturing organization (CMO) sites to ensure adherence to approved policies, SOPs, quality agreements, batch records, regulations and ensure timely documentation, notification/escalation, and resolution of any issues and nonconformities.Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls).Support quality investigations and manage CAPA (corrective and preventative actions) for CMO activities.Review and coordinate approval of all changes made to the manufacturing, testing, and control processes including those that are 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 and were conducted in accordance with regulatory filings, regulatory requirements and internal policies and procedures.Review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria.Provide QA oversight at contract manufacturing sites to ensure compliance with approved quality agreements and overall cGMP compliance for Moderna's drug substance and drug products.
This role requires approximately 40% international travel. Here's What You'll Bring to the Table: Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 5-8 years.Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in hosting and facilitating successful regulatory inspections.
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