Overview

Job Description Job Description Position SummaryThe Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site's development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach. The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization.The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks.The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally.Duties and Responsibilities Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program.Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA's Guidance for Industry, "Data Integrity and Compliance with Drug CGMP: Questions and Answers" (Final, 2018 .Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums.Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives. Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems.Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles. Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management.Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers. Lead or support site Data Integrity risk assessments, investigations, root cause analyses