DescriptionReporting 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 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)
- Support new product introductions (NPI) and ensure GMP readiness for manufacturing and supply chain operations
- Review 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 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
- Assist 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
Requirements- 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
- 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
