Associate Director, Quality Risk Management (Contract) 25335 Job at BioPharma Consulting JAD Group, Boston, MA

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  • BioPharma Consulting JAD Group
  • Boston, MA

Job Description

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

Job Tags

Full time, Contract work,

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