DescriptionReporting to the Executive Director, R&D Quality, the Sr. Manager, R&D Quality is responsible for providing Quality Assurance oversight by executing audits, ensuring compliance with GxP regulations, managing risk, supporting inspections, driving issue resolution, monitoring compliance metrics, updating procedures, and providing training.
This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.
Responsibilities (including, but not limited to):Quality Management System (QMS)- Support the maintenance and continuous improvement of the Quality Management System
- Manage quality events including Deviations, CAPAs, Quality issues, Change controls, and Risk assessments
- Perform trend analysis and communicate quality metrics to senior leadership
- Ensure quality processes remain aligned with: ICH E6(R3), FDA regulations, global requirements, and GxP industry standards
Inspection Readiness and Regulatory Support- Participate in inspection readiness activities across clinical development functions
- Support development and review of regulatory responses, CAPA commitments, and root cause analyses
- Participate in the conduct of mock and actual inspections
Audit Program Management- Plan, conduct, and manage investigator site audits, CRO audits, vendor audits, system and process audits, pharmacovigilance audits (as applicable)
- Review audit reports and assess findings for risk and regulatory significance
- Monitor audit observations through completion and CAPA effectiveness verification
Vendor Oversight- Partner with business functions to assess and monitor outsourced activities
- Evaluate vendor quality systems and qualification packages
- Support vendor selection, qualification, and ongoing oversight
- Ensure vendor compliance with contractual and regulatory requirements
Clinical Trial Quality Oversight- Provide proactive quality oversight throughout the clinical trial lifecycle
- Support implementation of critical-to-quality factors and Risk-Based Quality Management (RBQM) strategies
- Collaborate with study teams to identify and mitigate compliance risks and ensure appropriate escalation pathways
TMF and Data Integrity Oversight- Partner with functional teams to ensure inspection-ready trial master files
- Support TMF quality reviews and remediation efforts
- Assess data integrity controls across clinical systems and processes
- Review quality events involving: eTMF systems, EDC systems, IRT platforms, safety databases, laboratory vendors
SOP and Process Improvement- Author, review, and revise quality and operational procedures
- Ensure procedures remain compliant and inspection-defensible
- Lead process improvement initiatives that enhance efficiency while maintaining compliance
Training and Quality Culture- Deliver quality training programs across R&D functions
- Mentor operational teams on inspection readiness and compliance expectations
- Promote a culture of quality, transparency, and continuous improvement
- Serve as a trusted advisor to functional leadership
Requirements- Requires a Bachelor's degree in Life Sciences of related discipline is required (Advanced degree a plus) with 8+ years of biotech/pharmaceutical experience
- Clear record of success in R&D QA in the biotech/pharmaceutical industry
- Thorough understanding of FDA, ICH and EMEA guidelines and regulations
- Excellent time management skills and the ability to work with a sense of urgency
- Demonstrated leadership and collaboration skills in a cross-functional project team
- Strong oral and written communication including the ability to present information clearly and logically
- Ability to anticipate and address issues, prioritize, and manage multiple projects to meet critical deadlines
- Strong attention to detail and problem-solving skills
- Works effectively in a team environment
- 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
