Associate Director IT Quality & Validation

  • Reference: CJ47045yy
  • Job Type: Permanent
  • Location: Cork, Cork City
  • Category: Information Technology

 

Associate Director IT

Permanent

Cork/Nationwide

Role Responsibilities:

 

  • Partner with Business Process, or Data Owners and Technology Support & Delivery services over the life cycle of the IT Infrastructure
  • Responsible for design and implementation of a Quality and risk-based approach to ensure required IT Infrastructure controls are in place on GMP computerized Infrastructure that could potentially affect patient safety, product quality, and data integrity.
  • Maintain Quality Oversight for the quality/compliance, remediation, and support aspects of the Manufacturing Division
  • Remediation Support for issues anywhere in the IT Infrastructure space
    For the laboratory portion of the position, your focus will include:
    • Lead QA support for implementation of laboratory systems at all sites within your region
    • Drive global consistency of validation processes for laboratory systems and ensure systems are implemented consistently across sites
    • Support the implementation of the Lab of the Future
    • Collaboration with business functions & IT to assess/select/implement innovative technology solutions and upgrade existing solutions driving efficiency & compliance for global GMP and GXP lab systems
    • Support and guide the implementation of quality operation of IT Infrastructure including core requirements, policies, guidelines, SOPs, quality alerts, quality bulletins, white papers, best practices, flowcharts, and training.

 

 

Skills, Experience, and Qualifications:

 

To be successful in this role, which works with a diverse slate of customers across organizations globally, both strong technical skills and interpersonal skills are critical. Therefore, you should possess the following traits:

  • Strong stakeholder management and engagement skills with demonstrated success in Change Management.
  • Ability to understand business needs and map to IT technical solutions.
  • A strong laboratory background with understanding of the use and validation of laboratory systems from the end-users perspective
  • Experience performing SDLC on standalone instruments
  • The ability to proactively recognize and mitigate barriers to cross-functional initiatives and act as an intermediary across divisional, geographical, and cultural boundaries
  • Promote a culture of continuous improvement and respectfully challenging the status quo, while driving departmental/regional strategies that align with the organisations long term strategy
  • Bachelor’s Degree in a science, laboratory or engineering discipline with equivalent IT experience related to IT Systems Development, Implementation and/or IT Operations. Other Degrees will be considered based on experience.
  • 7-10 years of experience in a highly regulated environment. Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system for compliance to GMP regulations
  • 3-5 years of experience in delivering Laboratory IT or instrumentation or Qualified IT Infrastructure
  • Familiarity and practical experience in the implementation of quality systems in a pharmaceutical or biotechnology manufacturing environment.
  • Requirement for a background in Pharmaceutical Laboratory and Manufacturing Systems
  • IT Infrastructure related requirements for Identity and Access Management, Operating Systems, how IT Infrastructure is utilized will be a substantial portion of this position

Preferred Experience and Skills:

  • Experience in SDLC related to laboratory systems
  • An IT background in services, data centers and centrally deployed infrastructure within a data center environment or Validation/qualification work for this Quality role is preferred.
  • GAMP5 training
  • Background in GMP Change Management, Incident and problem management, and IT inventory management as it relates to IT Infrastructure and applications.
  • IT Infrastructure Quality related knowledge of Operating Systems, Virtualization of Servers and Networks, Storage, backup and restore technologies, bare metal systems and applications, data and databases, and services. 
  • Knowledge and understanding of Pharmaceutical Regulations and guidance such as ICH Q7, FDA 21CFR211.68, 21CFR11.10 , and the ability to understand and apply related internal Quality Systems and procedures related to computerized systems and IT Infrastructure are required.
  • CISA, CISP Certification and knowledge of frameworks established under COBIT and ITIL.

 

 

For a confidential discussion and more information on the role, please contact Phil on 021 4911064 or email phil.burchell@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!

 


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