Associate Director, Site Data Integrity and Computer System Validation Lead

BioSpace; Pleasant Prairie (WI); On-site; USD 111,000 - 178,200; Full time

Benefits offered by this job

Flexible benefits

401(k) participation

Comprehensive medical coverage

Job summary

A pharmaceutical company seeks an Associate Director for Site Data Integrity and Computer System Validation. This role emphasizes data management leadership and compliance, overseeing integrity initiatives and collaborating with functional data experts. Candidates should have at least 5 years in pharmaceutical QA roles, strong leadership, and technical skills. The position requires onsite presence with flexibility, a competitive salary between $111,000 and $178,200, and includes benefits such as a company-sponsored 401(k) and medical coverage.

Qualifications

• Minimum 5 years in pharmaceutical or medical device QA roles.
• Minimum 3 years in Computer System Quality Assurance.
• Minimum 3 years in data analytics.

Responsibilities

• Chair the site data lead team and advocate data management.
• Implement data integrity improvements across systems and processes.
• Represent the company during regulatory audits.

Skills

Leadership of cross-functional teams

Data integrity expertise

Technical writing skills

Problem-solving skills

Strong communication

Education

Bachelor's degree in engineering or computer science

Job description

Associate Director, Site Data Integrity and Computer System Validation Lead

Position Overview: The Site Data Leader will have primary responsibility for data management activities within the Lilly Kenosha County (LKC) site. They serve as an advocate for data management across the manufacturing site, chair the site data lead team, and ensure a robust Data Integrity Program exists and is maintained. The role interfaces with the M&Q Data Management organization and acts as a global data management subject matter expert to facilitate improvements in M&Q data-related corporate quality standards, business processes, and governance. They partner with functional area data experts to anticipate and resolve key data management and integrity issues, drive solutions aligned with corporate objectives, and transition to a site‑based data management and analytics leader role for routine production. The Associate Director, Quality Assurance, also provides computer system quality assurance oversight during start‑up and routine operation of the site.

Responsibilities

• Facilitate the Site Data Lead Team.
• Partner with global and site leadership to prioritize data integrity initiatives and secure cross‑functional resources.
• Collaborate with functional site data SMEs to ensure data management actions align with the established plan.
• Maintain Data Flow Maps to identify data integrity risks and define mitigation strategies.
• Implement programs to support data integrity improvements across documents, systems, and processes (e.g., audit trail reviews, user access, walk‑throughs, Site Self‑Inspection).
• Develop and enforce data standards (structure, metadata) and usage guidelines across multiple systems, managing data throughout its lifecycle.
• Drive data strategy actions (digitization, contextualization, visualization) to enable appropriate data use, robust decision making, productivity gains, and continuous improvement.
• Own site actions related to enterprise data management and integrity initiatives.
• Track and report site data management metrics and the status of data integrity action plans.
• Direct the operationalization of data management plans, including transition from paper‑based to digitized solutions.
• Enhance and sustain data management and integrity principles across the data lifecycle.
• Develop, maintain, and enforce the site Data Integrity Strategy.
• Design and deliver learning opportunities to strengthen the global M&Q Quality Culture in data management and integrity; provide training, coaching, feedback, and mentoring.
• Coach individuals on inspection interactions and lead preparation of data integrity topics for audit readiness.
• Network with other sites and central groups to gauge trends and develop internal improvement plans.
• Represent the company during regulatory audits, discussing data integrity expertise with authorities.
• Ensure compliance with Lilly global standards and regulatory guidelines.
• Assess current‑state data management practices, procedures, and system functionality (security, ER/ES, audit trails, data mapping, backup, retention, CSVA, qualification, investigations, training).
• Serve as the site liaison to the Global Data Management organization, providing feedback for improvement opportunities.
• Act as a global data management SME to facilitate and drive improvements in M&Q data standards, processes, and governance.
• Consult with Network and Global quality groups to ensure consistent, compliant project startup and design.
• Provide technical and quality review of project computer system documents, ensuring compliance with Lilly global standards and local procedures.
• Support the development of the site quality vision and strategy with a focus on CSQA topics.
• Build technical capability across cross‑functional teams and mentor new qualified staff.
• Lead project initiatives supporting the project and quality functions.
• Resolve or escalate compliance issues to project, site, and quality management.
• Participate in self‑led inspections and support during internal/external regulatory inspections.
• Ensure data integrity by design and leverage technology for data digitization and standardization.
• Design, replicate, and employ analytics and advanced analytics for competitive advantage within the site.

Qualifications

• Bachelor's degree required; engineering or computer science‑related field preferred.
• Minimum 5 years working in the pharmaceutical or medical device industry in QA roles.
• Minimum 3 years of experience in Computer System Quality Assurance/Computer System Validation.
• Minimum 3 years of experience with data analytics, including advanced analytics.
• Demonstrated successful leadership of cross‑functional teams and project management experience.
• Proficiency with GMP computer systems validation and governing regulations.
• Knowledge and application of data integrity regulatory guidance.
• Proven ability to apply analytics and advanced analytics for competitive advantage in manufacturing.
• Strong oral and written communication.
• Strong self‑management and organizational skills.
• Strong interpersonal interaction skills and ability to influence cross‑functional organizations.
• Strong technical writing skills.
• Strong problem‑solving and decision‑making skills.
• Previous facility or area start‑up experience.
• Previous qualification and validation experience (process automation and/or IT systems).
• Previous Six Sigma Green Belt or Lean training/experience.
• CQA certification from the American Society for Quality (ASQ) preferred.

Additional Information

• Position requires onsite presence with flex time available.
• Ability to work overtime as required.
• Ability to travel up to 10%.

EEO Statement

Lilly is a proud 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. Current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble. Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $111,000 - $178,200. Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). 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.