QA Product Complaint Manager

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, Quality Operations, the QA Product Complaint Manager will support end-to-end product complaint management for Viridian's externally manufactured and distributed products. This role is responsible for complaint intake, investigation coordination, complainant follow-up, quality metric reporting, and general QA Operations support while partnering with internal teams and external manufacturers, laboratories, device suppliers, and distribution partners to ensure timely, compliant, and inspection-ready complaint handling.

This role is intended to strengthen Viridian's product complaint process by ensuring complaints are assessed, investigated, documented, trended, and closed in a timely and compliant manner across internal functions and external partners.

This role is based in our Waltham, MA headquarters. Office-based employees are expected to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Manage end-to-end product complaint activities from intake, triage, investigation coordination, documentation, closure, and complainant follow-up in accordance with Viridian procedures and applicable regulatory expectations
• Serve as the primary QA owner for complaint records, including timely assessment, escalation, investigation assignment, documentation accuracy, closure readiness, and linkage to related quality events, as applicable
• Coordinate complaint investigations with external manufacturers, testing laboratories, distribution partners, device suppliers, and internal stakeholders for biologic, combination product, and distribution-related complaints
• Ensure investigations assess product impact, patient safety, device performance, lot history, retain/sample evaluation, distribution/shipping factors, and complaint trends, as applicable
• Manage complainant, reporter, affiliate, and partner follow-up, including information requests, sample/replacement coordination, response documentation, and complaint status or closure communications
• Develop, maintain, and report complaint quality metrics, including volume, aging, closure timeliness, recurrence, safety referral status, product/device trends, and partner responsiveness
• Prepare complaint summaries, trends, and metric updates for Quality Management Reviews, partner governance forums, leadership updates, and inspection/audit readiness

Requirements

• Requires 5 years of Quality Assurance experience in the biotechnology, pharmaceutical, biologics, or medical device industry
• Bachelor's degree in Life Science or Engineering is required
• Strong experience working with CDMOs in a virtual environment
• Experience with biologics, medical devices, or combination products preferred
• Previous product complaint handling experience in a regulated biotechnology, pharmaceutical, biologics, medical device, or combination product environment is required
• Demonstrated strong written and verbal communication skills, including the ability to communicate clearly with internal stakeholders, external partners, and complainants
• Proven mindset of proactive continuous improvement
• Efficient independent worker with ability to focus and drive for results
• Strong knowledge of US and global GMP regulations, ICH guidelines, and industry best practices
• Experience using Veeva Quality Management System or a comparable eQMS is required; direct Veeva experience is preferred
• Strong analytical and problem-solving skills with a proactive continuous improvement mindset
• Excellent attention to detail, organizational, and time management skills
• Ability to work independently and collaboratively in a fast-paced, team-oriented 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.

Salary : $118,000 - $145,000