Associate Director-Quality Assurance-Site Data Integrity

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Job Description

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 the sciences, engineering, or related field.

• Fluency in English (Read / Write) is required.

• Minimum of 5 years of experience in pharmaceutical manufacturing

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

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

• Understanding of IT system design, controls, and usage.

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

• Ability to work on multiple concurrent project initiative.

Other Requirements

• Available to travel (domestic and international) on an average of <10%.

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $169,400

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.

#WeAreLilly