Associate Director-Quality Assurance-Site Data Integrity

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 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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

Job Responsibilities

The Site Data Leader will have primary responsibility for data management activities within the site. This includes data integrity. He/she will be an advocate for data management across the manufacturing site and will chair the site data lead team.

The Site Data Leader will ensure that a robust Data Integrity Program exists within the site providing strong project management leadership to advance the site’s agenda. This requires interface with the Manufacturing & Quality (M&Q) Data Management organization, serving as a global data management subject matter expert to facilitate and drive improvements in M&Q data-related corporate quality standards, business processes, organizational design, and governance necessary for ongoing data integrity effectiveness.

This role will partner with functional area data experts to anticipate and resolve key data management and integrity issues while driving solutions that impact the site and align with corporate objectives. This role will leverage a 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 regulatory compliance, consistency, and sustainment.

This role will be responsible for ensuring the site’s data integrity training program facilitates the sustainment of its data integrity continuous improvement journey. The Site Data Leader will also be responsible for advancing data management standards to ensure consistency and consumability of data to drive process improvements.

Job Requirements

• Experience in leading inspection readiness with effective results obtained through interaction/discussion with regulatory officials related to data integrity expertise in areas as necessary

• Demonstrated 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.

• Strong project management and organizational skills are a must.

• Demonstrated ability to interpret and apply standards to different situations by understanding site needs and applying good problem-solving skills.

• Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership.

• Ability to influence and contribute to strategy and agenda in the area of data integrity.

• Strong knowledge and technical expertise in areas of cGMPs, production practices, and quality systems.

• Recognized understanding of regulations governing data integrity.

• Ability to build relationships across dimensions of difference, ask questions & invite others to contribute.

• Demonstrated business acumen.

• Speak up with ideas as well as concerns and ensure the psychological safety of others.

• Demonstrated learning agility and ability to think creatively; try new ideas and apply learnings.

• Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.

• Strong collaboration with colleagues at all levels.

• Demonstrated courage & integrity.

• Demonstrated success in influencing without authority.

• Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.

• Highly flexible, adapting to changes in priorities, requirements and processes is required

Basic Qualifications

• Bachelor’s degree or higher in sciences, engineering, or related field is required.

• Fluency in English and Spanish (Read / Write) is required

Experience Required:

• Minimum of 5 years of experience in GMP operations

• Understanding and working knowledge of domestic and international data integrity regulations and other policies/regulations as applicable.

• Knowledge of IT system design, controls, and usage or

• Working knowledge of laboratory, operations, and maintenance processes including automation.

• Ability to communicate effectively with all levels and functions in the organization.

• Ability to work on multiple concurrent project initiative

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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