R&D Quality Leader: Inspections & Compliance

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

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