Director, QC 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 Executive Director, Quality Control, the Director, QC Operations will lead teams responsible for critical QC functions, including stability program management, supplier oversight, LIMS administration, data trending, and management of key quality systems such as reserve and retention. This role will partner closely with internal stakeholders and external organizations to develop, implement, and continually improve operational strategies while maintaining full compliance with applicable quality and regulatory requirements.

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 stability team, including oversight of external partners to support all stages of program development
• Collaborate closely with CMC functions, including Analytical Development and Process Development, to ensure aligned QC support
• Lead the implementation, configuration, and ongoing management of the LIMS system
• Develop, manage, and enhance QC data trending programs to support proactive quality oversight
• Oversee external partners (e.g., CMOs, CTLs) to ensure adherence to quality and regulatory expectations
• Manage regulatory reserve and retention systems in accordance with global requirements
• Support regulatory submissions by authoring and reviewing relevant CMC sections
• Prepare QC personnel for inspection readiness, support vendor audits, and serve as the QC subject matter expert during inspections
• Oversee quality records within assigned areas, including robust management of OOS/OOT investigations and related deliverables

Qualifications:

• Requires a BS, MS, or PhD in a life science discipline with a minimum of 12 years of relevant industry experience
• Strong background in analytical methods and data analysis, including compendial methods
• Demonstrated leadership experience in QC operations and oversight of external CMOs/CTLs
• Deep knowledge of cGMP, ICH, FDA, and EU regulations and guidance
• Proven hands-on experience with LIMS administration, configuration, implementation, and validation
• Experience with data trending tools (e.g., JMP) and statistical analysis; ability to identify, monitor, and troubleshoot trends
• Strong people leadership skills, with experience coaching, developing, and managing staff at various levels
• Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 5%
• 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
• Competitive medical, dental, and vision coverage
• Fertility and mental health programs
• 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 mental, financial, and proactive physical health programs covered by Viridian

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.