Manager, Quality Operations

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 Manager, Quality Operations, will take the lead in overseeing and optimizing GMP systems and processes to ensure alignment with corporate goals and strict adherence to regulatory standards. This role requires a strategic thinker and a hands-on leader, responsible for ensuring compliance with all relevant policies and procedures while working closely with internal teams to drive quality excellence. In addition, the Manager, Quality Operations will serve as the key liaison with external partners, including CMOs, and vendors, fostering strong relationships to ensure seamless quality operations across the board.This role may be based in our Waltham, MA headquarters or remote. Office-based employees are required to work in the office three (3) days a week. For remote role, travel to headquarters may be required at the discretion of management. Responsibilities (including, but not limited to):Oversee CMO activities to ensure products are manufactured in accordance with regulatory requirements, product registrations, and quality agreementsPerform batch record reviews and lot dispositions per established proceduresConduct and review product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs)Support new product introductions (NPI) and ensure GMP readiness for manufacturing and supply chain operationsReview and approve controlled documents supporting product manufacture and testing, including master batch records, product specifications, analytical methods, protocols, and reports.Lead continuous improvement initiatives to enhance quality assurance processesCollaborate cross-functionally with departments such as CMC, Regulatory Affairs, and Supply Chain to ensure quality standards are metEnsure compliance with internal quality systems, including document control, training, and audit readinessAssist with regulatory inspections and internal audits, ensuring resolution of observations and implementation of corrective actionsQuality review of regulatory filingsEstablish and track Key Performance Indicators (KPIs) for CDMO quality performanceParticipate in Quality Management ReviewsRequirementsMinimum of 5+ years of Quality Assurance experience in Biotechnology and/or pharmaceutical industryBachelor’s degree in Life Science or Engineering is requiredStrong experience working with CDMOsExperience in combination products ideal, although not requiredDemonstrated strong written and verbal communication skillsProven 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 supporting clinical phases through commercialization and lifecycle managementProficiency in electronic Quality Management Systems (e.g., Veeva, TrackWise)Demonstrated ability to manage batch disposition, deviation investigations, and change control processesStrong analytical and problem-solving skills with a proactive continuous improvement mindsetExcellent attention to detail, organizational, and time management skillsStrong written and verbal communication 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.)Ability to travel up to 20% domestically and internationally, including visits to CMOs and Viridian's officesThe salary range for this position is commensurate with experienceViridian 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 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