Manager Quality Compliance

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, Quality Operations, the Manager, Quality Compliance, will support end-to-end product complaint management for Viridian’s externally manufactured and distributed products. This role is responsible for complaint intake, investigation coordination, complainant follow-up, quality metric reporting, and general QA Operations support while partnering with internal teams and external manufacturers, laboratories, device suppliers, and distribution partners to ensure timely, compliant, and inspection-ready complaint handling.

This role is intended to strengthen Viridian’s product complaint process by ensuring complaints are assessed, investigated, documented, trended, and closed in a timely and compliant manner across internal functions and external partners.

This role is based in our Waltham, MA headquarters. Office-based employees are expected to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Manage end-to-end product complaint activities from intake, triage, investigation coordination, documentation, closure, and complainant follow-up in accordance with Viridian procedures and applicable regulatory expectations
• Serve as the primary QA owner for complaint records, including timely assessment, escalation, investigation assignment, documentation accuracy, closure readiness, and linkage to related quality events, as applicable
• Coordinate complaint investigations with external manufacturers, testing laboratories, distribution partners, device suppliers, and internal stakeholders for biologic, combination product, and distribution-related complaints
• Ensure investigations assess product impact, patient safety, device performance, lot history, retain/sample evaluation, distribution/shipping factors, and complaint trends, as applicable
• Manage complainant, reporter, affiliate, and partner follow-up, including information requests, sample/replacement coordination, response documentation, and complaint status or closure communications
• Develop, maintain, and report complaint quality metrics, including volume, aging, closure timeliness, recurrence, safety referral status, product/device trends, and partner responsiveness
• Prepare complaint summaries, trends, and metric updates for Quality Management Reviews, partner governance forums, leadership updates, and inspection/audit readiness