Associate Director-Quality Assurance-Site Data Integrity

Eli Lilly and Company • Us, IN

5d • Onsite

About The Position

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.

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.
• 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.
• 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.

Nice To Haves

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

Responsibilities

• Primary responsibility for data management activities within the site, including data integrity.
• Advocate for data management across the manufacturing site and chair the site data lead team.
• Ensure a robust Data Integrity Program exists within the site, providing strong project management leadership.
• Interface with the Manufacturing & Quality (M&Q) Data Management organization, serving as a global data management subject matter expert.
• Facilitate and drive improvements in M&Q data-related corporate quality standards, business processes, organizational design, and governance.
• Partner with functional area data experts to anticipate and resolve key data management and integrity issues.
• Drive solutions that impact the site and align with corporate objectives.
• Leverage a deep understanding of GMP data flows (electronic and paper), data management and integrity principles in operational processes, and Computer System Validation methodologies.
• Ensure the site’s data integrity training program facilitates the sustainment of its data integrity continuous improvement journey.
• Advance data management standards to ensure consistency and consumability of data to drive process improvements.
• Lead inspection readiness with effective results obtained through interaction/discussion with regulatory officials related to data integrity expertise.
• Interpret and apply standards to different situations by understanding site needs and applying good problem-solving skills.
• Write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership.
• Influence and contribute to strategy and agenda in the area of data integrity.
• Build relationships across dimensions of difference, ask questions & invite others to contribute.
• Speak up with ideas as well as concerns and ensure the psychological safety of others.
• Try new ideas and apply learnings.
• Share ideas and solutions effectively with management and colleagues.
• Collaborate with colleagues at all levels.
• Take initiative, be assertive, lead by example and build high-quality relationships.
• Adapt to changes in priorities, requirements and processes.

Benefits

• company bonus (depending, in part, on company and individual performance)
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager