Global Quality Data Integrity Program Owner – Sr. Director in Indianapolis

Job Description

Join American pharmaceutical leader Eli Lilly and Company, currently hiring Global Quality Data Integrity Program Owner – Sr. Director in Indianapolis, Apply Lilly careers in Indianapolis Indiana.

 

Position : Global Quality Data Integrity Program Owner – Sr. Director

Location : Indianapolis, Indiana

Job id: R-32202

 

Job Details

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.Organization Overview At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.The Sr. Director – Global Quality Data Integrity Program Owner is a role that is responsible for oversight of the Data Integrity program for regulated (e.g., GMP) areas and serves as a subject matter expert across the enterprise.  The role sets the technical direction and strategy for Data Integrity at Lilly through the ownership of the Lilly Quality Standard.  This also includes ownership of the integrated roadmap in Manufacturing and Quality (MQ) for the Data Integrity program, influencing senior management on the direction of the data integrity program and providing routine updates to senior management through the global data integrity metrics.  This role will provide leadership of the MQ Site Data Leader forum, setting direction for the internal manufacturing sites and being accountable for harmonizing activity to ensure expectations of Data Integrity are being consistently implemented, executed and ultimately that data integrity is embedded in the quality management system holistically.The Sr. Director – Global Quality Data Integrity Program Owner partners with functional area data experts at the global level to anticipate and resolve key data integrity issues.  They leverage deep understanding of GMP data flows (electronic and paper), the application of data management and integrity principles in operational processes and Computer System Validation methodologies to ensure applicable business processes are maintained at the global level to ensure regulatory compliance, consistency, and sustainment.  In addition to a heavy focus on GMP business areas, this role will restart and lead the Data Integrity Enterprise team which ensures communication and drives harmonization where possible across the Enterprise.  This role will define and lead other data integrity governance groups where appropriate (e.g., MQ Groups focused on external manufacturing) as the business continues to evolve the embedding of data integrity into the Quality Management System.This Sr. Director – Global Quality Data Integrity Program Owner is a member of the MQ Data Management Organization that delivers foundational standards, processes, and governance to support the MQ approach to information and data management across different functions centrally and at all the MQ sites.  The MQ Data Management Organization will focus on the information and data that is derived in and supports the safe manufacture of quality products throughout the product lifecycle.  They will define and promote the use of information management standards, best practices and controls and communicate and promote the value of the MQ data assets. Responsibilities:Owns the Integrated Global Data Integrity Roadmap for Manufacturing and Quality.  Works with MQ Site Data Leaders to ensure site project plans are in accordance with the Global DI Roadmap.  Routinely reports Global M&Q DI Metrics to the Global MQ Data Lead Team and Manufacturing Policy Committee (MPC).Proactively develops and maintains the requirements and content associated with GQS105 (Data Integrity and Good Documentation Practices) and LQS105 (Data Integrity and Documentation Practices) in order to ensure that Lilly meets current regulatory requirements and company expectations.Chairs the Data Integrity Enterprise Team and defines and leads any other applicable governance groups to support the direction of the Integrated Data Integrity Roadmap.Leads and/or supports the assessment, development, and implementation of critical and complex global projects in support of continual and significant data integrity related improvements.Has decision making authority for the M&Q Data Integrity program in partnership with the Global MQ Data Lead Team and MPC.Provides consultation/education to sites/business areas on the interpretation and implementation of the requirements associated with Data Integrity and Good Documentation Practices.Is continually aware of current industry trends and regulatory agency interpretation of cGxP requirements related to Data Integrity.  Engages internally with Senior Leadership to influence changes throughout the Lilly Quality Management System. Works externally to influence regulatory standards by engaging in Data Integrity Specific groups and/or participates as the Lilly representative on Industry external data integrity related publications.Develops Data Integrity applied knowledge in individuals across the enterprise. Coaches and mentors colleagues, including peers, associates, and management.Basic Qualifications:Minimum of 10 years direct experience in pharmaceutical manufacturing/laboratory setting.Previous experience with designing and implementing a Data Integrity (DI) planAdditional Skills & Preferences:Previous experience with designing or executing a pharmaceutical quality management system.Strong knowledge and technical expertise in areas of CGMPs, applied data integrity and good documentations within GMP.Demonstrated working knowledge of IT systems that support quality processes (e.g., SAP, TrackWise).Demonstrated leadership across global organization.Pharmaceutical development experience demonstrated cross-functional/sites/affiliates partnership.Understanding and working knowledge of domestic and international data integrity regulations and other policies/regulations as applicable.Ability to interpret data integrity theory and convert into application across a variety of settings including but not limited to Quality Control Laboratories and Production Areas.Demonstrated understanding of data integrity concepts including but not limited to Audit Trail Review expectations, Data Integrity Assessment processes, and Document and Data control requirements.Demonstrated ability to interact and influence across all levels of the organization.Proficient with the usage of the MS Office suite (e.g., Word, Excel, PowerPoint, Access, Project, Visio).Demonstrated ability to communicate and deliver constructive feedback to customers, including oral, written and presentation communication skills.Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills.Demonstrated ability to develop business presentations and effectively communicate the concepts to a multiple range of personnel.Recognized understanding of regulations governing data integrity and good documentation.Demonstrated cross-functional leadership.Proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment.Demonstrated Strong project management and organizational skills are a must.Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills.Demonstrated ability to write technical documents, develop business presentations and effectively communicate the concepts to a wide range of personnel including senior leadership.Ability to define strategy and influence senior leadershipAdditional Information:Availability to travel (domestic and international) on an average of <10%.Position requires visits to manufacturing sites.Able to attend training courses, conferences, or association meetings to continue to gain knowledge, to share such information with other members of the group or company to increase awareness and to train others in the implementation of these practices.  Additionally to influence external standards.Role is a global role and has ability to support someone outside Indianapolis and OUS as long as they are hosted at an internal to Lilly Manufacturing site. Relocation to Indianapolis is desirable, however hosting at a Lilly Manufacturing site can be considered so long as applicant is within daily driving distance of the host site.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).     Career Tags : Eli Lilly and Company jobs hiring in Indianapolis, Jobs nearby me in Indianapolis Indiana, Eli Lilly careers in Indianapolis Indiana, Indianapolis jobs hiring, Global Quality Data Integrity Program Owner – Sr. Director job nearby in Indianapolis. 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