Senior Manager, R&D Quality

Description At 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, R&D Quality, the Sr. Manager, R&D Quality is responsible for providing Quality Assurance oversight by executing audits, ensuring compliance with GCP, GLP, and/or GVP 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 pathwaysTMF 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…