Manager, Device Quality Assurance

Rhythm is seeking a Manager, Device Quality Assurance to ensure quality and regulation-based compliance during the manufacture and distribution of clinical products. The role will manage quality systems, review documentation, and support issue resolution across the supply chain.

Requirements

• Serve as the Quality contact for external manufacturing partners producing combination products and sterile drug products.
• Review and approve batch records, device history records, test results, and other quality documents from contract sites.
• Monitor contract manufacturer performance through routine reviews, meetings, and quality metrics.
• Responsible for the review and approval of process validation documents, protocols and reports, Master Batch Records and Executed Batch Records at the Contract Development and Manufacturing Organization (CDMO).
• Assists in the review and verification of process data assuring compliance with data integrity and traceability requirements as appropriate.
• Supports regulatory filings (e.g., Investigational New Drugs (INDs), Annual Reports, Stability Reports) by reviewing data, ensuring compliance with regulatory procedures.
• Utilizes GMP-regulated quality management systems, including document control, change control, deviations/complaints, and corrective and preventative actions (CAPAs).
• Facilitates the creation, review, and approval of relevant SOPs and work instructions relevant to CMC activities.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Discretionary annual bonus
• Restricted stock units