Associate Director, Quality Operations

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 Associate Director, Quality Operations will lead quality oversight of Viridian’s external manufacturing and supply network supporting EU and international operations. The role provides hands-on oversight of batch record review, lot disposition, deviations, change controls, suppliers, commercial supply, and international expansion. The Associate Director, Quality Operations will act as the primary quality liaison for CMOs, CDMOs, testing laboratories, distributors, and logistics partners and support batch certification by Viridian’s contracted Qualified Person (QP).

This role is fully remote and may be located in the United States or the United Kingdom. Travel to US headquarters for meetings may be required at the discretion of management.

Responsibilities (including, but not limited to):

Provide quality oversight of external partners supporting drug substance, drug product, packaging, labelling, testing, distribution, and logistics activities

Serve as a primary quality liaison with external manufacturing and testing partners, including routine governance, issue escalation, and performance monitoring

Perform batch record reviews and lot dispositions in accordance with established procedures

Review and oversee product- and lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs)

Own supplier qualification, requalification, performance monitoring, and related Quality Agreements across the external vendor network

Negotiate, approve, and maintain Quality Agreements with CMOs, CDMOs, testing laboratories, distributors, and logistics partners

Establish and track KPIs for CMO, CDMO, and supply chain quality performance and escalate trends through Quality Management Review

Oversee distribution and third-party logistics quality, including cold-chain management, shipping-lane qualification, and assessment and disposition of temperature excursions

Provide quality oversight of serialization, labeling, and artwork controls

Support the contracted QP by reviewing complete batch certification packages and resolving certification-related questions

Review and approve controlled documents supporting manufacture and testing, including master batch records, specifications, analytical methods, protocols, and reports

Support new product introductions, commercial launch readiness, and ongoing GMP readiness across EU and international manufacturing and supply chain operations

Ensure compliance with internal quality systems, including document control, training, and audit readiness

Assist with regulatory inspections and internal audits, including resolution of observations and implementation of corrective actions

Lead continuous improvement initiatives across quality assurance and external manufacturing oversight processes