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Collins McNicholas

KEY AREAS OF JOB ACCOUNTABILITY:

  • Effectively manage a portfolio of projects (e.g. Knowledge Management, Data Integration, Electronic Batch Records, Data Analytics/Visualization) using project management best practices and following required Systems Development Life Cycle (SDLC) policies
  • Identify and report on project success criteria results, test and deployment management activities
  • Elicit requirements using interviews and workshops, document analysis and business process descriptions, use cases, scenarios, business analysis, task and workflow analysis
  • Create and distribute documentation as needed: Functional Requirements, Business Requirements, Use Cases and End-to-End testing documents, Data Flow Diagrams
  • Serve as the conduit between the customer community (internal and external customers) and the software development team (external vendors)
  • Perform/Co-Ordinate system unit and integration testing where necessary
  • Ensure appropriate IT processes, procedures, and standards are in place
  • Ensure schedules, financials, scope, and performance requirements of the various project are met
  • Build and foster effective relationships between the business and IT
  • Oversee vendor relationships
  • Anticipate operational and tactical risks to effectively manage client expectations
  • Management of issues, risks and organisational change management to ensure successful and on-time project delivery
  • Coordinate issue resolution with internal and external technical support providers
  • Introduce best practice and process improvement ideas wherever appropriate
  • Ensure adherence to FDA computer systems validation compliance
  • Ensure that all aspects of work conform to agreed approved standards and set procedures.

 

REQUIREMENTS

Minimum Education & Experience Requirements:

  • Bachelor’s Degree in Computer Science, Information Systems, or a related Science field; Project Management Institute (PMI) certification or AGILE/SCRUM training a plus
  • Previous experience in the biotechnology and/or pharmaceutical industries is desirable
  • Minimum of 5 years of relevant experience within pharmaceutical/biotech industry a must
  • Must have a proven track record to lead a small-to-mid-sized team
  • Experience with enterprise information management systems and software vendor selection
  • Demonstrated ability to manage several complex projects at the same time
  • Experience working with third-party implementers.

 

Knowledge/Skills Needed:

  • Technical proficiency in the following areas: server, storage, backup/recovery, virtualization, networking, security, and Citrix.
  • Strong knowledge of concepts, designs, and best practices in converged infrastructure environments and cloud services.
  • Demonstrated ability to develop architecture strategies and associated roadmaps.
  • Effective project management and facilitation skills.
  • Strong communication, presentation and vendor management skills.
  • Highly adaptive with ability to work independently and function in a team as needed.

Technical Knowledge/Skills Needed:

  • Demonstrated Project Management skills, PMI or equivalent certification preferred
  • Demonstrated ability managing cloud/SaaS based application implementations (e.g AWS Microservices, Tibco Spotfire, Tableau)
  • Domain knowledge of pharmaceutical chemistry or engineering (CMC) requirements/guidance/compliance areas (e.g. USP, GAMP5, S88, GxP regulations) preferred
  • Strong analytical skills required, including a thorough understanding of how to interpret customer business needs and translate them into application and operational requirements
  • Excellent verbal and written communication skills and the ability to interact professionally with a diverse group, executives, managers, and subject matter experts
  • Ability to develop and analyze business requirements and functional specifications for business software solutions
  • Experience in biotech and pharmaceutical industry and best practices
  • Exhibits strong team skills, including facilitating group sessions

For further information on this positon please contact Gillian Nicholson at gillian.nicholson@collinsmcnicholas.ie

or for a confidential discussion please call Gillian on 0906478104

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