DescriptionReporting 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
