We are seeking an experienced Associate Director of Quality Risk Management to lead and enhance Quality Risk Management (QRM) efforts within the Research & Development (R&D) Quality organization. This individual will play a pivotal role in developing and executing an enterprise-wide QRM strategy aligned with regulatory expectations and industry best practices. The successful candidate will bring a strong background in clinical science, quality assurance, and compliance, and will partner cross-functionally to embed risk-based thinking into all aspects of R&D operations.

Key Responsibilities:

• Develop, implement, and continuously improve quality risk management tools, procedures, and methodologies across R&D.
• Map processes and value streams to support effective risk management and generate standard operating procedures (SOPs) and work instructions.
• Collaborate on software qualification and validation activities related to QRM tools, including user acceptance testing (UAT).
• Partner with R&D teams to proactively identify, assess, prioritize, and mitigate risks.
• Facilitate risk reviews, governance meetings, and promote consistent, strategic approaches to risk management.
• Support communication strategies to enhance awareness of QRM principles throughout the R&D organization.
• Use data analytics to improve risk visibility and support decision-making.
• Contribute to continuous improvement initiatives within the R&D quality framework.
  
  
  

Requirements

Qualifications:

• Strong background in Quality Assurance, Compliance, or Risk Management in the biotech or pharmaceutical industry.
• Proven ability to develop strategic risk mitigation plans and influence cross-functional teams.
• Experience with quality systems and risk assessment methodologies.
• Excellent communication, collaboration, and stakeholder engagement skills.
• Lean Six Sigma certification preferred.
• Clinical science and/or clinical trial assay knowledge is a strong plus.
  
  
  

Benefits

• Schedule: Full-time, Contract
• Location: Boston, MA (On-site/Hybrid)
• Contract position