The position is located in the Global Quality GxP IT Quality Assurance department within the Data Integrity tower. It is responsible for providing support to the Lead of the GxP Data Integrity program across the end-to-end product lifecycle, ensuring that regulatory and Client requirements are thoroughly and effectively addressed promptly.
Key Responsibilities and Major Duties
• Provide oversight for the governance, management, and coordination of activities related to the Data Integrity Governance Program, including directing, developing, and maintaining Data Integrity compliance activities across the end-to-end product and all Client sites and internal functions in alignment with relevant governmental regulations and guidelines.
• Assist in conducting data integrity gap assessments, develop remediation plans and strategies, and manage tasks towards execution
• Develop and utilize metrics and KPIs to assure programs’ success, and develop data analytics management processes
• Utilize visualization technologies to create information from various data sets and sources
• Ensure compliance with all Company policies and procedures, including safety rules and regulations
• Support the various audit programs across and within departments around data integrity concepts and training
Key Competencies – knowledge, skills, abilities, other
• Cross-functional experience in three or more areas (i.e. IT, Computer System Validation, Research, Analytical/QC, QA, Engineering, manufacturing, Regulatory etc.) is desired
• Recent Data Integrity experience in a GxP environment
• Ability to collaborate and lead cross-functionally to help drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites
• Provide subject matter expertise in regulatory requirements, expectations, specifications/methods/compendia, manufacturing technology, and/or quality assurance is required.
• Ability to build alignment with business partners including research & development, commercial operations and manufacturing regional and site leaders
• Ability to demonstrate strategic thinking capability with strong project management focus as well as focus on execution of strategic decisions while balance conflicting priorities
• 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 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 a multicultural workforce.
• Excellent team player attitude
Education
A university bachelor's degree in Life Sciences, with at least 5 years of experience in Data Integrity and GMP/CSV required.
Travel
• Travel to Client sites (both US and outside US) may be required
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