Key Responsibilities:
* Provide oversight of environmental and facilities monitoring programs, including data review and trending for a GMP manufacturing site.
* Ensure accuracy, completeness, and integrity of data generated to support facility and manufacturing operations.
* Monitor and manage raw material sampling and testing programs, ensuring alignment with the appropriate lifecycle stage.
* Lead cross-functional teams to investigate and resolve facility deviations and excursions.
* Maintain oversight and approval responsibilities for quality records including change controls, deviations, CAPAs, supplier quality records, documentation, training, and quality review processes.
Qualifications:
* Bachelor’s degree in a relevant scientific or engineering discipline required.
* 8–10 years of experience in GMP-regulated biopharma or biotech environments, focused within Quality functions.
* Strong working knowledge of FDA and EMA regulatory requirements, with direct experience supporting regulatory inspections.
* Demonstrated experience in quality systems and supplier quality program management.
* Proven ability to lead continuous improvement initiatives and facilitate cross-functional collaboration.
* Solid project management and meeting facilitation capabilities.
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