Associate Director, Quality Control

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, 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 elevate 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 performance trending and data integrity expectations in regulated environments
• Ability to operate effectively in a dynamic, fast-paced biotechnology environment
• Strong written and verbal communication skills with experience preparing technical and regulatory documentation
• Strong commitment to ethical standards
• Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, SharePoint)
• Ability to travel up to 10%
• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Medical, dental, and vision insurance
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various fertility, mental, financial, and proactive physical health programs

Viridian…