Manager, Quality Operations Compliance

Description

At Viridian, we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, strategic risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.


Reporting to the Director, Quality Assurance, the Quality Operations Compliance Manager is responsible for leading and maintaining the quality compliance framework supporting Viridian's commercial operations, with a strong focus on product complaint management, quality system performance, and operational governance. This role ensures alignment with cGMP, GxP, and global regulatory requirements through oversight of quality systems, performance metrics, inspection readiness, and external partner compliance. The successful candidate will collaborate closely with internal cross-functional stakeholders and external CMOs/CDMOs to drive robust quality oversight and continuous improvement across the product lifecycle.

This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.

Responsibilities (including but not limited to):

• Lead end-to-end product complaint management for clinical and commercial products , including intake, triage, investigation oversight, root cause analysis, CAPA development, trending, and timely closure in compliance with regulatory requirements

• Own complaint trending and signal detection activities , escalating adverse trends and potential patient or product quality risks

• Review and approve complaint investigations and CAPAs from external partners, ensuring regulatory and quality system compliance

• Own and maintain Quality Operations dashboards , ensuring tracking, trending, and reporting of key quality indicators (KQIs) and compliance metrics across the quality system

• Develop, maintain, and present Quality Management Review (QMR) metrics , providing clear visibility of quality system performance, risks, and improvement opportunities to senior management

• Ensure effective implementation and continuous improvement of core QMS processes, including deviations, change controls, CAPAs, risk management, and document control

• Lead Supplier Review Boards, including development and maintenance of CMO performance metrics, scorecards, and routine quality performance assessments

• Provide quality oversight of external manufacturing partners (CMOs/CDMOs), including review of deviations, CAPAs, and effectiveness checks related to supplied product

• Support internal audits, partner audits, and health authority inspections, serving as a subject matter contact for complaints and quality system performance

• Partner cross-functionally with Technical Operations, Supply Chain, Analytical Development, Regulatory Affairs, and Pharmacovigilance to ensure integrated handling of complaints, investigations, and regulatory commitments

• Author, review, and approve SOPs, work instructions, investigation summaries, complaint reports, and other quality documentation supporting clinical and commercial operations

Requirements

• Requires a Bachelor's degree in a relevant STEM discipline with 5+ years of experience in quality management and CDMO oversight, or a Master's degree in a related field with 3+ years of experience in quality management and CDMO oversight
• Demonstrated experience leading product complaint management in a regulated pharmaceutical or biotechnology environment, including complaint trending and health authority reporting support
• Proven experience developing and maintaining quality dashboards, KQIs, and management review metrics to support data-driven decision making
• Strong understanding of supplier quality management, including use of quality scorecards and performance metrics

• Familiarity with cGMP, ICH, FDA, and EU guidelines
• Excellent communication and collaboration skills; ability to work independently and in cross-functional teams
• Strong judgment, influence, and stakeholder-management skills , with the ability to communicate quality risks, trends, and recommendations clearly to both technical and non-technical audiences, including senior leadership
• Combination product and medical device experience preferred , including understanding of applicable FDA and EU regulations (e.g., 21 CFR 4, 820) and hands-on experience supporting medical device complaint handling and investigations within a pharmaceutical or biotechnology quality system
• Proven mindset of proactive continuous improvement
• Efficient independent worker with ability to focus and drive for results
• Strong attention to detail
• Ability to work in a fast-paced environment and to handle multiple tasks
• 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.