Sr. Manager, R&D Quality

Viridian Therapeutics, Inc.; Waltham (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive pay/stock options

Medical, dental, vision insurance

Disability coverage

401(k) company match

Employee stock purchase plan

Generous vacation & holidays

Wellness programs

Job summary

Viridian Therapeutics, Inc. is seeking a Sr. Manager, R&D Quality to provide QA oversight across clinical development, ensuring compliance with GCP, GLP, and GVP.

The role is based in Waltham, MA, with a three‑day in‑office requirement. You will drive audits, inspections readiness, risk management, and quality culture across R&D functions. The candidate should have a Life Sciences degree with 8+ years in biotech/pharma QA, strong regulatory knowledge, and proven leadership in cross‑functional

Qualifications

• Requires a Bachelor’s degree in Life Sciences or related field; advanced degree a plus.
• Clear track record in R&D QA within biotech/pharmaceutical industries.
• Thorough understanding of FDA, ICH, and EMEA guidelines and regulations.
• Excellent time management and ability to work with urgency.
• Demonstrated leadership and cross‑functional collaboration.
• Strong communication, both written and oral, with ability to present clearly.
• Ability to manage multiple projects and meet deadlines.
• Attention to detail and problem solving.
• Team player with ethical commitment.

Responsibilities

• Provide QA oversight across the clinical development lifecycle.
• Audit program management for investigator sites, CROs, vendors, and systems.
• Support inspection readiness activities and regulatory responses.
• Lead risk management and RBQM initiatives; trend quality metrics to leadership.
• Oversee TMF quality reviews, data integrity, and remediation.
• Author/revise quality and operational procedures; drive process improvements.
• Deliver training and promote a culture of quality across R&D.

Skills

QA oversight

Audits

GCP/GLP/GVP

Risk management

Inspection readiness

Training

Cross-functional leadership

Communication

Microsoft Office

Education

Bachelor’s degree in Life Sciences

Advanced degree a plus

Tools

Microsoft Office

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 Director, R&D Quality, the Sr. Manager, R&D Quality is responsible for providing Quality Assurance oversight by executing audits, ensuring compliance with GCP, GLP, and/or GVP 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
• 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

Qualifications:

• 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
• 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.