Manager, Quality Operations

Responsibilities

• Oversee CMO activities to ensure products are manufactured in accordance with regulatory requirements, product registrations, and quality agreements
• Perform batch record reviews and lot dispositions per established procedures
• Conduct and review product and/or lot-related deviations, complaints, CAPAs, change controls, and annual product quality reviews (APQRs)
• Serve as the key liaison with external partners, including CMOs and vendors, fostering strong relationships to ensure seamless quality operations
• Lead continuous improvement initiatives to enhance quality assurance processes
• Collaborate cross-functionally with departments such as CMC, Regulatory Affairs, and Supply Chain to ensure quality standards are met
• Ensure compliance with internal quality systems, including document control, training, and audit readiness
• Afford assistance with regulatory inspections and internal audits, ensuring resolution of observations and implementation of corrective actions
• Quality review of regulatory filings
• Establish and track Key Performance Indicators (KPIs) for CDMO quality performance
• Participate in Quality Management Reviews

Qualifications

• Minimum of 5+ years of Quality Assurance experience in Biotechnology and/or pharmaceutical industry
• Bachelor’s degree in Life Science or Engineering is required
• Strong experience working with CDMOs
• Experience in combination products ideal, although not required
• Demonstrated strong written and verbal communication skills
• 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 supporting clinical phases through commercialization and lifecycle management
• Proficiency in electronic Quality Management Systems (e.g., Veeva, TrackWise)
• Demonstrated ability to manage batch disposition, deviation investigations, and change control processes
• Strong analytical and problem-solving skills with a proactive continuous improvement mindset
• Excellent attention to detail, organizational, and time management skills
• Strong written and verbal communication 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.)
• Ability to travel up to 20% domestically and internationally, including visits to CMOs and Viridian's offices

Pay & Benefits

Viridian offers a competitive salary and stock options for all employees. Benefits include:

• 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
• Variety of 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.