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Curium Pharma · 1 day ago

Principal Quality and Regulatory Systems Analyst

Maryland Heights Plant

Full-time

Hybrid

Lead/Staff

8+ years exp

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. The role involves working closely with Quality and Regulatory business functions to ensure reliable and efficient operations of all related systems, including Learning Management and Document Management.

Pharmaceutical

Responsibilities

Strong system analysis capability derived from software development experiences

Business acumen and the ability develop and manage third parties to service level agreements

Experience working with Quality and Regulatory systems in a regulated industry

Capable of working with the business to develop system rationalization and optimization strategies

Experience working with Systems Development Life Cycle methods (water fall & agile)

Participates in staff meetings and team meetings as required

Develops understanding of general industry usage of supported technologies

Develops basic understanding of business processes and business dependencies on supported technologies

Develops relationships within I/S and with supported customers to improve collaboration and teamwork necessary to accomplish organizational objectives

Participates in a development planning process where employee career goals are defined & understood and development activities are incorporated into the employee objectives

Other duties as assigned with or without accommodation

Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)

Qualification

QualityRegulatory SystemsGMPValidationSystems Development Life CycleSystem AnalysisProject ManagementBusiness AcumenInterpersonal SkillsProblem Solving

Required

Bachelor Degree or Technical School degree in Information Technology, Business or related degree program; work experience in lieu of degree acceptable

Eight or more years of information systems experience with a demonstrated capability in Quality and Regulatory Systems is required

Experience with GMP and Validation requirements is required

Strong systems analytics with the ability to manage large number applications is required

Ability to work independently to gather, process and document business requirements and translate into functional solutions that meet the business requirements

Ability to manage multiple projects simultaneously and balance priorities effectively

Strong interpersonal skills with the ability to collaborate with members of the business and third party support personnel to develop system requirements and resolve system issues

Strong hands-on analysis and problem solving experience preferably with Quality and Regulatory systems is required