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 Operations, 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:

• Provide strategic oversight of Viridian’s GMP stability programs across multiple clinical and commercial products
• Develop and evolve stability strategies aligned with global regulatory requirements and product lifecycle needs
• Ensure stability programs are designed to support regulatory submissions, shelf-life extensions, and commercialization activities
• Oversee stability activities performed by contract testing laboratories (CTLs) and CMOs, ensuring compliance, quality, and timeliness
• Review and approve stability protocols, reports, test methods, and technical changes proposed by external partners
• Drive effective collaboration and issue resolution with external laboratories
• Review and interpret stability data and analytical results to ensure data integrity and scientific soundness
• Perform and oversee trend analysis of stability and QC testing data to identify product or method performance trends
• Prepare trend reports and stability summaries to support internal governance and regulatory filings
• Contribute to CMC regulatory submissions, including IND, BLA, and global filings
• Support health authority inspections and regulatory inquiries related to QC stability programs
• Ensure stability programs remain compliant with global GMP and ICH stability guidance
• Lead or support deviation, OOS/OOT investigations, and implement robust root cause analysis and corrective actions
• Own and drive change controls related to stability programs, including protocol updates, shelf-life extensions, and program modifications
• Facilitate cross-functional stability governance meetings and communicate program status, risks, and mitigation strategies to stakeholders
• Partner with Quality Assurance, Regulatory Affairs, Manufacturing, and Technical Development to ensure alignment across the product lifecycle
• Drive continuous improvement initiatives to enhance stability, program efficiency and compliance
   

Requirements

• Master’s degree with 8+ years of relevant experience OR Bachelor’s degree with 10+ years of experience in biopharmaceutical quality control or analytical development
• Demonstrated experience leading GMP stability programs for biologics supporting clinical and/or commercial products
• Strong knowledge of global stability requirements and regulatory expectations (e.g., ICH guidelines and regional regulatory agencies)
• Experience supporting regulatory inspections and health authority interactions
• Proven ability to interpret analytical data and communicate stability trends to cross-functional teams and senior leadership
• Experience working with contract laboratories and external manufacturing partners
• Strong technical knowledge of analytical and bioanalytical techniques, including ELISA, chromatography (HPLC/UPLC), electrophoresis, spectroscopy, and compendial methods used for biopharmaceuticals
• Experience leading investigations and quality system processes (deviations, OOS, CAPA, change control)
• Familiarity with data analysis tools and statistical methods (e.g., JMP) 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
• Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, SharePoint

Salary commensurate with experience

Viridian offers a comprehensive benefits package including:

•       Competitive pay and stock options for all employees
•       Medical, dental, and vision insurance
•       100% Paid Parental Leave 
•       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 Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.