Job Description:

Purpose: 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.

Responsibilities:

-Conduct risk assessments, including the identification of hazards, estimation of risks, and evaluation of risk mitigation strategies.

-Work closely with the Quality Risk Management Quality System Owner and support other related Quality System processes as needed.

-Collaborate with cross-functional teams to develop and implement risk mitigation plans.

-Stay up-to-date with industry trends, regulatory changes, and emerging risks, and proactively recommend improvements to the R&D Quality Risk Management Program.

-Maintain deep understanding of the Quality Risk Management process, including linkages and interactions of all impacted functional areas.

Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines. Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle. Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success. Deliver quality project solutions to business problems or issues within defined budgets and/or timelines. Provide expert project guidance/support proactively through project completion. Provide tracking, reporting, and presentation to management and users. 7 years experience

Experience/Skills:

-Bachelors' degree required in a scientific or technical field (Chemistry, Pharmacy, Biology, Microbiology or Engineering) required.

-Minimum of 6 years of risk management industry experience in a regulated environment.

-Effective communication skills, with an ability to work and influence cross-functionally.

-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.

-Excellent organizational skills, attention to detail, and strong analytical skills.

Preferred experience:

-Experience in two or more of the following areas: Quality Assurance, Compliance, Regulatory, Clinical Operation, Pharmacovigilance, Manufacturing, or Combination products or Medical devices.

-Experience using risk management software.

Pay Rate: $50-54/Hr *Salary will be commensurate with experience