Hybrid Details: Onsite 3 days/week (days are flexible)

Duration: 12 months to start

Job Description

• This person 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.
  
  

Responsibilities

• Develop, implement, and refine R&D quality risk management tools, methodologies, and processes to align with the client's�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 Global Quality Risk Management team for QRM software qualification and validation activities, such as User Acceptance Testing, as required
• Provide 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.
  
  

Requirements

• Strong background in Quality Assurance, Compliance, or Risk Management within the pharmaceutical or biotech industry.
• Leadership and communication skills - stakeholder management skills, with the ability to influence and align diverse teams.
• Proficiency in risk assessment methodologies and quality management systems.