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Latitude, Inc. CMO Manager in Gaithersburg, Maryland

Job Type: Full Time

Salary: $100,000 - 130,000 /year

The CMO Manager represents the Operations organization in the oversight and monitoring of the GMP production in contract manufacturing sites to ensure that product specifications and schedules are met. Additionally, the CMO Manager is responsible for the statistical analysis of data related to product quality, efficacy, safety, and support investigations.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Act as the primary relationship manager and point of contact with the CMOs while working closely with internal quality and process experts for the oversight and coordination of activities relating to the production of the product.

  • Batch Records Review

  • Drives, leads, and troubleshoots quality investigations at contract manufacturers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions.

  • Ensures contract manufacturers are compliance ready for regulatory inspections and monitor inspection progress during inspections.

  • Review of documents from contract manufacturers for compliance with MiMedx policies and procedures.

  • Implement and monitor MiMedx key performance indicators at contract manufacturers.

  • Ensure quality checks on on-going operations at contract manufacturers are performed

  • Ensure Good Documentation Practices

  • Adherence to approved Batch Record instructions & final release process for manufactured products.

  • Troubleshoots product quality defects and nonconforming product

  • Provides audit support of CMO, as required.

  • Identify, design, and implement process and system improvements.

  • Report on performance at CMOs for overall site metrics, key issues to be presented at the relevant Operations Review Meeting

  • Manage competing priorities to meet targets and timelines

EDUCATION/EXPERIENCE:

  • Requires a bachelor?s degree

  • Strong experience with leading and managing quality investigations and Materials Review Board.

  • Strong working knowledge of cGMPs (US, Canada, and Europe) requirements as applicable to biological products.

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