What are the responsibilities and job description for the Manager/Senior Manager, Quality Operations position at Viridian Therapeutics, Inc?
At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.
Reporting to the Director of Quality Operations, the Manager/Senior Manager of Quality Operations, will take the lead in overseeing and optimizing GMP systems and processes to ensure alignment with corporate goals and strict adherence to regulatory standards. This role requires a strategic thinker and a hands-on leader, responsible for ensuring compliance with all relevant policies and procedures while working closely with internal teams to drive quality excellence. In addition, the Manager/Senior Manager of Quality Operations will serve as the key liaison with external partners, including CMOs, and vendors, fostering strong relationships to ensure seamless quality operations across the board.
This role may be based in our Waltham, MA headquarters or remote. Office-based employees are required to work in the office three (3) days a week. For remote role, travel to headquarters may be required at the discretion of management.
Responsibilities (including, but not limited to):
- Oversee CMO activities to ensure products are manufactured in accordance with regulatory requirements, product registrations, and quality agreements
- Perform batch record reviews and lot dispositions per established procedures
- Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs)
- Support new product introductions (NPI) and ensure GMP readiness for manufacturing and supply chain operations
- Review and approve controlled documents supporting product manufacture and testing, including master batch records, product specifications, analytical methods, protocols, and reports
- Lead continuous improvement initiatives to enhance quality assurance processes
- Collaborate cross-functionally with departments such as CMC, Regulatory Affairs, and Supply Chain to ensure quality standards are met
- Ensure compliance with internal quality systems, including document control, training, and audit readiness
- Assist with regulatory inspections and internal audits, ensuring resolution of observations and implementation of corrective actions
- Quality review of regulatory filings
- Establish and track Key Performance Indicators (KPIs) for CDMO quality performance
- Participate in Quality Management Reviews
