Associate Director, Quality Control

Description 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 Control Analytical, the Associate Director, Quality Control will primarily manage Viridian’s stability program performed by outside testing laboratories. The Associate Director will manage CMO/CTL, review data and prepare CoA. This position works closely with other functions within Viridian and external CMO/CTLs.This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

Provide strategic leadership to the QC Analytical team, including oversight of external partners to support all stages of program development

Develop and evolve phase-appropriate specifications, reference standards, and critical reagents in accordance with global regulatory requirements

Analyze and communicate complex analytical data to internal stakeholders, senior leadership, and external partners

Establish priorities, lead cross-functional activities, and ensure timely delivery of QC commitments through effective influence and collaboration

Lead method lifecycle management for QC owned methods including transfers, validations, performance monitoring, improvements and change impact assessments

Provide strategic and operational leadership for external CMOs and CTLs supporting analytical testing, stability, and product release activities for clinical-stage biopharmaceutical and combination products, including accountability for performance, quality, timelines, issue resolution, and escalation

Align technical expectations across internal teams and external partners, review data and deliverables, resolve issues, and drive partner accountability

Identify and escalate analytical, compliance, or execution risks early, with a recommended path forward

Lead or support deviation, OOS/OOT investigations, and implement robust root cause analysis and corrective actions

Contribute to CMC regulatory submissions, including IND, BLA, and global filings and regulatory inquiries. Support inspection readiness activities and vendor audits

Serve as the QC subject matter expert during inspections and regulatory inquiries

Partner with Quality Assurance, Regulatory Affairs, Manufacturing, and Technical Development to ensure alignment across the product lifecycle

Requirements

Requires a Master’s degree with 8+ years of relevant experience or a Bachelor’s degree with 10+ years of experience in biopharmaceutical quality control or analytical development.

Demonstrated experience with QC analytical method lifecycle activities for biologics, including method transfer, validation, performance monitoring, improvement, and expansion to support EU regulatory and market requirements

Experience working with contract laboratories and external manufacturing partners, including data review, technical issue resolution, and partner oversight

Experience supporting regulatory inspections and health authority interactions

Strong technical knowledge of analytical, bioanalytical, and device test methods used for biopharmaceutical and combination products, including ELISA, chromatography (HPLC/UPLC), electrophoresis, spectroscopy, compendial methods, and device functional performance testing

Experience leading investigations and quality system processes (deviations, OOS, CAPA, change control)
Proficiency with data analysis tools and statistical methods (e.g., JMP) supporting specification setting and method…