Data Integrity Implementation Specialist

Pe Global

Dublin North

Data Integrity Implementation Specialist (Consultant) – Quality. Position Summary. The position is in the Global Quality Enterprise GxP e-Systems department within the Data Integrity Governance group and is responsible for driving the implementation of an effective GxP Data Integrity Governance Program (the Program) across the end-to-end (R&D, Operations and Supply Chain) product lifecycle to ensure that regulatory and client’s requirements are addressed in a thorough effective, and timely manner. Drive implementation of Data Integrity Governance Program milestones through coordination and execution of cross-functional deliverables. Write and/or edit procedural documentation and training materials to ensure an ongoing state of Data Integrity compliance across the GxP product lifecycle, as well as all Alexion sites and internal functions. Principal Responsibilities. Provide hands-on development, execution and coordination of activities related to Data Integrity Governance Program including development of DI plans, assessment tools, process maps and gaps remediation plans and execution. Provide active support during regulatory agency and third party inspections. Develop and utilize metrics and KPIs to assure programs’ success. Facilitate Data Integrity Community of Practice. Provide program and project management of Data Integrity Governance Program. Develop and deliver cross-functional DI training and knowledge management. Promote cross – functional partnership developing “DI by design” sustainable state. Qualifications. Cross-functional experience in three or more areas (i.e. Research, Analytical/QC, QA, Engineering, manufacturing, Regulatory etc.) is desired. Experience in Pharmaceutical or BioTech manufacturing or clinical research desired. Proven record successfully implementing DI Governance program. Ability to collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites and internal functions. Subject matter expertise in DI regulatory requirements and risk management. Ability to build alignment with business partners. Demonstrated strong project management focus as well as focus on tactical execution of strategic decisions while balancing conflicting priorities. Demonstrated strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk. Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments. Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights. Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing and distribution processes. Must understand industry accepted software development and validation life cycle programs. Excellent interpersonal skills, including written and verbal communication. Strong sense of ethics, diplomacy and discretion. Commitment to Quality. Strong critical thinking to analyze complex situations and discern critical issues. Able to work effectively with multicultural workforce. Excellent team player attitude. Education. Bachelor’s degree in Scientific, Engineering, or Business discipline required. Lean Six Sigma training desirable. PMI knowledge and certification desirable. Competencies. Extensive knowledge of the effective Risk Management practices. Data Integrity and GAMP 5 expert. Detail oriented with a bias for action. Demonstrated cross-functional networking skills. Strong written and verbal communication skills. Demonstrated problem solving capabilities. Capable of identifying and mitigating risks. Accountable business partner with a focus on collaborating and delivering results. May require international travel (10 %) Please send in your CV for the attention of Robert Carroll or contact 021 4520311 for more information. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

1920 days ago