Job Title: R&D Quality Risk Management Consultant
Start Date: ASAP
Duration: 12 months + possible extension
Logistics: Hybrid. 3 days on site every week to Boston, MA.
Hours/week: 40
Additional Notes: The following was provided in Atrium's initial email with the JD:
Must have experience with risk management in pharma
Ability to create and define processes
Someone who is comfortable with ambiguity for this role
Implemented technology for system management before - Think user requirements/business requirements
Privacy and/or ethics background would be nice to have
8-10 yrs exp.
Associate Director level role
R&D Quality experience
Experience w/creating quality systems - Deviations, CAPA, risk assessments etc.
Need experience in the clinical world
JOB DESCRIPTION:
Position Summary:
The Contractor for Quality Risk Management (QRM) in Research & Development (R&D) Quality will assist with developing and implementing a strategic, enterprise-wide approach to QRM within R&D Quality. This individual plays a key role in ensuring the global Quality Risk Management strategy links to the R&D Quality Risk Management framework.
This role partners across Quality functions to ensure a holistic, proactive, and integrated approach to risk, and will collaborate with cross-functional teams to assess, mitigate, and govern risks, embedding risk-based thinking into decision-making processes.
Key Responsibilities:
Develop, implement, and refine R&D quality risk management tools, methodologies, and processes to align with Vertex global quality strategy and industry best practices and regulatory expectations.
Process and value stream mapping of Risk Management processes and creation of procedures and work instructions
Collaborate with the Globa Quality Risk Management team for QRM software qualification and validation activities, such as User Acceptance Testing, as required
Partners with R&D functions to identify, assess, and prioritize risks, providing strategic guidance on mitigation plans.
Facilitate risk reviews, governance discussions, and cross-functional alignment to ensure consistent risk management practices.
Support risk communication strategies and drive awareness of quality risk management principles across R&D.
Contribute to continuous improvement initiatives, leveraging data analytics to enhance risk visibility and decision-making.
Qualifications & Experience
Strong background in Quality Assurance, Compliance, or Risk Management within the pharmaceutical or biotech industry.
Strategic thinker with the ability to analyze complex situations, synthesize information, and drive actionable solutions.
Excellent stakeholder management skills, with the ability to influence and align diverse teams.
Proficiency in risk assessment methodologies and quality management systems.
Lean Six Sigma certification preferred
This role is On-site/Hybrid, and is based in Boston.
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