Cache of job #13910955

Job Title

Associate Director - Quality Assurance IT

Employer

Brightwater

Location

Tipperary, Cork

Description

Responsibilities: • Partner with Business Process or Data Owners and Technology Support & Delivery services over the life cycle of the IT Infrastructure for all site based and local company 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 company’s Manufacturing Division and IT Infrastructure Globally including at site and at Global / Regional Data Centres. • Involvement with the QA Audit as needed and review of audit or inspection reports. • As part of this Quality Unit (QU) role, review and approve IT Infrastructure changes. • Regulatory Audit and Inspection Support. • 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 company 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 the company 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, flow charts, and training. • 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 company’s long term strategy. • Build trust and develop new relationships with internal and external clients to effectively collaborate and achieve successful outcomes at a regional/global level. Qualifications. • Bachelor’s Degree in a Science, Engineering discipline or IT. • 7-10 years of experience in a highly regulated environment. • 3-5 years of experience in delivering Laboratory IT or instrumentation or Qualified IT Infrastructure. • Experiences in a Pharmaceutical or biotechnology manufacturing environment. • IT Infrastructure related requirements for Identity and Access Management, Operating Systems, • Strong technical skills and interpersonal skills are critical. Preferred Experience and Skills: • Experience in SDLC related to laboratory systems. • An IT background in services and data centres. • GAMP5 training. • Background in GMP Change Management, Incident and problem management. • Background in IT inventory management as it relates to IT Infrastructure and applications. • IT knowledge of Operating Systems, Virtualization of Servers and Networks, Storage, backup and restore technologies. • Knowledge and understanding of Pharmaceutical Regulations and guidance. • CISA, CISP Certification and knowledge of frameworks established under COBIT and ITIL. Due to the nature of this position, candidates must have either a valid EU passport or a valid Stamp 4 visa . This job originally appeared on RecruitIreland.com.

Date Added

2107 days ago

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