Senior Manager, R D Quality Viridian Therapeutics, Inc. - 3.5 Waltham, MA Job Details Full-time $147,000 - $180,000 a year 20 hours ago Benefits Stock options Paid parental leave AD&D insurance Employee stock purchase plan Paid holidays Disability insurance Health insurance Dental insurance Parental leave Vision insurance 401(k) matching Qualifications Biotechnology Microsoft Excel Microsoft Outlook Team leadership Drug regulation ICH guidelines Bachelor's degree Task prioritization Pharmaceutical company experience Leading team collaboration initiatives SharePoint Managing projects Clinical quality assurance standards Project leadership Cross-functional communication FDA regulations Full Job 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 Executive Director, R D Quality, the Sr. Manager, R D Quality is responsible for providing Quality Assurance oversight by executing audits, ensuring compliance with GxP regulations, managing risk, supporting inspections, driving issue resolution, monitoring compliance metrics, updating procedures, and providing training. 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): Quality Management System (QMS) Support the maintenance and continuous improvement of the Quality Management System Manage quality events including Deviations, CAPAs, Quality issues, Change controls, and Risk assessments Perform trend analysis and communicate quality metrics to senior leadership Ensure quality processes remain aligned with: ICH E6(R3), FDA regulations, global requirements, and GxP industry standards Inspection Readiness and Regulatory Support Participate in inspection readiness activities across clinical development functions Support development and review of regulatory responses, CAPA commitments, and root cause analyses Participate in the conduct of mock and actual inspections Audit Program Management Plan, conduct, and manage investigator site audits, CRO audits, vendor audits, system and process audits, pharmacovigilance audits (as applicable) Review audit reports and assess findings for risk and regulatory significance Monitor audit observations through completion and CAPA effectiveness verification Vendor Oversight Partner with business functions to assess and monitor outsourced activities Evaluate vendor quality systems and qualification packages Support vendor selection, qualification, and ongoing oversight Ensure vendor compliance with contractual and regulatory requirements Clinical Trial Quality Oversight Provide proactive quality oversight throughout the clinical trial lifecycle Support implementation of critical-to-quality factors and Risk-Based Quality Management (RBQM) strategies Collaborate with study teams to identify and mitigate compliance risks and ensure appropriate escalation pathways TMF and Data Integrity Oversight Partner with functional teams to ensure inspection-ready trial master files Support TMF quality reviews and remediation efforts Assess data integrity controls across clinical systems and processes Review quality events involving: eTMF systems, EDC systems, IRT platforms, safety databases, laboratory vendors SOP and Process Improvement Author, review, and revise quality and operational procedures Ensure procedures remain compliant and inspection-defensible Lead process improvement initiatives that enhance efficiency while maintaining compliance Training and Quality Culture Deliver quality training programs across R D functions Mentor operational teams on inspection readiness and compliance expectations Promote a culture of quality, transparency, and continuous improvement Serve as a trusted advisor to functional leadership Requires a Bachelor's degree in Life Sciences of related discipline is required (Advanced degree a plus) with 8+ years of biotech/pharmaceutical experience Clear record of success in R D QA in the biotech/pharmaceutical industry Thorough understanding of FDA, ICH and EMEA guidelines and regulations Excellent time management skills and the ability to work with a sense of urgency Demonstrated leadership and collaboration skills in a cross-functional project team Strong oral and written communication including the ability to present information clearly and logically Ability to anticipate and address issues, prioritize, and manage multiple projects to meet critical deadlines Strong attention to detail and problem-solving skills Works effectively in a team environment Strong commitment to ethical standards Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.) 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 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.