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Project Manager
3 months ago
About the Role:
We are seeking a Risk Management Specialist to oversee, execute, deploy, and continuously improve our R&D Quality System to ensure GxP alignment and compliance with evolving regulations.
The ideal candidate will have a background in a scientific or technical field and at least 6 years of experience in risk management within a regulated environment.
Responsibilities:
Conduct risk assessments, including hazard identification, risk estimation, and evaluation of mitigation strategies.
Collaborate with cross-functional teams to develop and implement risk mitigation plans.
Stay informed about industry trends, regulatory changes, and emerging risks, and make proactive recommendations for improvements to the R&D Quality Risk Management Program.
Maintain a deep understanding of the Quality Risk Management process and its interactions with other functional areas.
Education Qualification:
Bachelor's degree in a scientific or technical field (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) required.
Required Skills:
Effective communication skills with the ability to work cross-functionally.
Thorough understanding of policies, regulations, standards, and best practices of risk management.
Excellent organizational skills, attention to detail, and strong analytical skills.
Preferred Experience:
Experience in Quality Assurance, Compliance, Regulatory, Clinical Operation, Pharmacovigilance, Manufacturing, or Combination products/Medical devices.
Experience using risk management software.
This role involves managing and directing activities associated with projects related to non-IT business applications.
The successful candidate will collaborate with project sponsors, business units, and users to identify project scope, develop project initiatives, implement project requirements, and ensure project success.
This is a full-time, on-site position with no testing required. If you meet the qualifications and are looking to join a dynamic team in the risk management industry, we encourage you to apply.
