QA Product Complaint Manager

DescriptionAt 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 expectationsServe 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 applicableCoordinate complaint investigations with external manufacturers, testing laboratories, distribution partners, device suppliers, and internal stakeholders for biologic, combination product, and distribution-related complaintsEnsure investigations assess product impact, patient safety, device performance, lot history, retain/sample evaluation, distribution/shipping factors, and complaint trends, as applicableManage complainant, reporter, affiliate, and partner follow-up, including information requests, sample/replacement coordination, response documentation, and complaint status or closure communicationsDevelop, maintain, and report complaint quality metrics, including volume, aging, closure timeliness, recurrence, safety referral status, product/device trends, and partner responsivenessPrepare complaint summaries, trends, and metric updates for Quality Management Reviews, partner governance forums, leadership updates, and inspection/audit readinessRequirementsRequires 5+ years of Quality Assurance experience in the biotechnology, pharmaceutical, biologics, or medical device industryBachelor’s degree in Life Science or Engineering is requiredStrong experience working with CDMOs in a virtual environmentExperience with biologics, medical devices, or combination products preferredPrevious product complaint handling experience in a regulated biotechnology, pharmaceutical, biologics, medical device, or combination product environment is requiredDemonstrated strong written and verbal communication skills, including the ability to communicate clearly with internal stakeholders, external partners, and complainantsProven mindset of proactive continuous improvementEfficient independent worker with ability to focus and drive for resultsStrong knowledge of US and global GMP regulations, ICH guidelines, and industry best practicesExperience using Veeva Quality Management System or a comparable eQMS is required; direct Veeva experience is preferredStrong analytical and problem-solving skills with a proactive continuous improvement mindsetExcellent attention to detail, organizational, and time management skillsAbility to work independently and collaboratively in a fast-paced, team-oriented environmentStrong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)The salary range for this position is commensurate with experienceViridian offers a comprehensive benefits package including:Competitive pay and stock options for all employeesMedical, dental, and vision insurance100% Paid Parental Leave Short- and long-term disability coverageLife, Travel and AD&D401(k) Company Match with immediate company vestEmployee Stock Purchase planGenerous vacation plan and paid company holiday shutdownsVarious fertility, mental, financial, and proactive physical health programsViridian 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.Employee Type: FT Exempt