Senior R&D Quality Leader — GxP, Audits & CAPA

Kids for the Future; Waltham (MA); On-site; USD 147,000 - 180,000; Full time

Benefits offered by this job

Competitive pay and stock options

Medical, dental, and vision insurance

Disability coverage

Life, Travel and AD&D

401(k) Company Match

Employee Stock Purchase plan

Generous vacation and holidays

Wellness programs

Job summary

Viridian Therapeutics, Inc. is seeking a Sr. Manager, R&D Quality to provide QA oversight and drive compliance with GCP, GLP, and GxP standards in a Waltham-based role. You will lead audits, manage risk, support inspections, and ensure quality across the clinical lifecycle.

The role requires a Bachelor’s degree in Life Sciences with 8+ years in biotech/pharma, strong leadership, and excellent communication. Office presence is required three days per week at the MA headquarters.

Qualifications

• Requires a Bachelor’s degree in Life Sciences or related discipline 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 (Word, PowerPoint, Excel, Outlook, SharePoint, etc.).

Responsibilities

• Quality Management System (QMS): Maintain and improve the QMS and related processes.
• Inspection Readiness and Regulatory Support: Support inspections and regulatory responses.
• Audit Program Management: Plan and conduct audits, review findings, and drive CAPA.
• Clinical Trial Quality Oversight: Oversee quality across the clinical trial lifecycle.
• TMF and Data Integrity Oversight: Ensure inspection-ready TMF and data integrity controls.
• SOP and Process Improvement: Author and revise quality procedures, drive improvements.
• Training and Quality Culture: Deliver training and promote a culture of quality.

Skills

Leadership

Cross-functional collaboration

Oral & written communication

Time management

Attention to detail

Problem solving

Team player

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 and drive compliance with GCP, GLP, and GxP standards in a Waltham-based role. You will lead audits, manage risk, support inspections, and ensure quality across the clinical lifecycle.

The role requires a Bachelor’s degree in Life Sciences with 8+ years in biotech/pharma, strong leadership, and excellent communication. Office presence is required three days per week at the MA headquarters.