Biotech Quality Compliance Lead — Complaints & Investigations

Kids for the Future; Waltham (MA); Hybrid; USD 118,000 - 145,000; Full time

Benefits offered by this job

Stock options

Medical, dental, vision insurance

401(k) plan

Job summary

Viridian Therapeutics, Inc. is seeking a Manager, Quality Compliance to lead end-to-end product complaint management for externally manufactured and distributed products.

You will own intake, investigation coordination, and follow-up with complainants, ensuring documentation and timely closure in a regulated environment. Reporting to the Director of Quality Operations, you will partner with internal teams and external manufacturers to ensure inspection-ready complaint handling, data trending,

Qualifications

• Requires 5+ years of QA experience in biotech, pharmaceutical, biologics, or medical device industries.
• Bachelor’s degree in Life Science or Engineering is required.
• Strong knowledge of GMP, ICH, and QA best practices.
• Experience working with CDMOs in a virtual environment.
• Experience with biologics, medical devices, or combination products preferred.
• Proven written and verbal communication skills for internal and external stakeholders.
• Proactive continuous improvement mindset.
• Ability to work independently and collaboratively in a fast-paced environment.

Responsibilities

• Manage end-to-end product complaint activities from intake to closure.
• Serve as primary QA owner for complaint records and ensure documentation accuracy.
• Coordinate investigations with external manufacturers, testing laboratories, distribution partners, and internal stakeholders.
• Assess product impact, patient safety, device performance, lot history, and trends in investigations.
• Develop, maintain, and report complaint quality metrics and KPIs.
• Prepare complaint summaries and trend updates for leadership reviews and audits.

Skills

Quality Assurance

Regulatory knowledge

Veeva QMS

Communication

Problem solving

Education

Bachelor's degree (Life Science or Engineering)

Tools

Veeva QMS

Job description

Viridian Therapeutics, Inc. is seeking a Manager, Quality Compliance to lead end-to-end product complaint management for externally manufactured and distributed products.

You will own intake, investigation coordination, and follow-up with complainants, ensuring documentation and timely closure in a regulated environment. Reporting to the Director of Quality Operations, you will partner with internal teams and external manufacturers to ensure inspection-ready complaint handling, data trending,