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.

About the role

The Site Data Leader will have primary responsibility for data management activities within the site, including data integrity. This role will advocate for data management across the manufacturing site and chair the site data lead team. The Site Data Leader will ensure a robust Data Integrity Program exists within the site, providing strong project management leadership to advance the site’s agenda.

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

Responsibilities

• Lead inspection readiness with effective results obtained through interaction/discussion with regulatory officials related to data integrity expertise.
• Plan and carry out tasks with a high degree of independence while working effectively in a team environment.
• Apply strong project management and organizational skills to drive the site’s data integrity agenda.
• Interpret and apply standards to different situations by understanding site needs and applying 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, and invite others to contribute.
• Demonstrate business acumen, speak up with ideas and concerns, and ensure the psychological safety of others.
• Think creatively, try new ideas, and apply learnings to drive continuous improvement.
• Collaborate with colleagues at all levels and demonstrate courage and integrity.
• Influence without authority, take initiative, and lead by example to build high-quality relationships.
• Adapt to changes in priorities, requirements, and processes with flexibility.
• Travel domestically and internationally as required.

Requirements

• 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.
• Strong knowledge and technical expertise in cGMPs, production practices, and quality systems.
• Recognized understanding of regulations governing data integrity.
• Demonstrated proficiency in project management and organizational skills.
• Ability to interpret and apply standards to different situations.
• Demonstrated ability to write technical documents and develop business presentations.
• Ability to influence and contribute to strategy and agenda in data integrity.
• Ability to build relationships across diverse teams and foster psychological safety.
• Demonstrated learning agility, creativity, and ability to apply new ideas.
• Highly motivated, enthusiastic to learn, and able to share ideas effectively.
• Strong collaboration skills with colleagues at all levels.
• Demonstrated courage, integrity, and success in influencing without authority.
• Ability to take initiative, be assertive, and lead by example.
• Highly flexible and adaptable to changes in priorities and processes.

Qualifications

• Understanding and working knowledge of domestic and international data integrity regulations and policies.
• 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.

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.

Pay

The anticipated wage for this position is $115,500 - $169,400. Full-time equivalent employees are also eligible for a company bonus (depending on company and individual performance).

Benefits

• Comprehensive benefit program, including medical, dental, vision, and prescription drug benefits.
• Eligibility to participate in a company-sponsored 401(k) and pension plan.
• Vacation benefits and certain time off and leave of absence benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).