Randstad Life Sciences US

Hybrid role: M & F (remote) T, W, and Thur (onsite): 8:00-5:00 pm hours. Primarily responsible for the oversight, execution, deployment and continuous improvement of R&D Quality System to ensure appropriate GxP alignment and compliance to evolving regulations.. Bachelors' degree required in a scientific or technical field (Chemistry, Pharmacy, Biology, Microbiology or Engineering) required.. Experience in two or more of the following areas: Quality Assurance, Compliance, Regulatory, Clinical Operation, Pharmacovigilance, Manufacturing, or Combination products or Medical devices.. Risk assessments performed during drug development and capturing information

risk management specialist

Risk Management Specialist6 MonthsNorth Chicago, ILHybrid role: M & F (remote) T, W, and Thur (onsite): 8:00-5:00 pm hours Purpose:<ul><li>Primarily responsible for the oversight, execution, deployment and continuous improvement of R&D Quality System to ensure appropriate GxP alignment and compliance to evolving regulations.</li></ul>Responsibilities:<ul><li>Conduct risk assessments, including the identification of hazards, estimation of risks, and evaluation of risk mitigation strategies.</li><li>Work closely with the Quality Risk Management Quality System Owner and support other related Quality System processes as needed.</li><li>Collaborate with cross-functional teams to develop and implement risk mitigation plans.</li><li>Stay up-to-date with industry trends, regulatory changes, and emerging risks, and proactively recommend improvements to the R&D Quality Risk Management Program.</li><li>Maintain deep understanding of the Quality Risk Management process, including linkages and interactions of all impacted functional areas.</li></ul>Experience/Skills:<ul><li>Bachelors' degree required in a scientific or technical field (Chemistry, Pharmacy, Biology, Microbiology or Engineering) required.</li><li>Minimum of 6+ years of risk management industry experience in a regulated environment.</li><li>Effective communication skills, with an ability to work and influence cross-functionally.</li><li>Thorough understanding of polices, regulations, standards, and best practices of risk management. The scope of responsibilities is broad and requires the ability to communicate, understand and direct individuals in highly specialized risk management background.</li><li>Excellent organizational skills, attention to detail, and strong analytical skills.</li></ul>Preferred experience:<ul><li>Experience in two or more of the following areas: Quality Assurance, Compliance, Regulatory, Clinical Operation, Pharmacovigilance, Manufacturing, or Combination products or Medical devices.</li><li>Experience using risk management software.</li><li>Risk assessments performed during drug development and capturing information</li><li>Will be delegating meetings to discuss with multiple stakeholders, host meetings, providing updates</li><li>Looking for experience creating risk management files, maintaining risk management files, drug and medical devices,</li><li>Critical thinking, technical background using systems that support risk management, compliance background</li></ul>

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