Advisor/Sr. Advisor - Inspection Lead

BioSpace; Indianapolis (IN); On-site; USD 121,500 - 198,000; Full time

Benefits offered by this job

Comprehensive benefit program

401(k) participation

Flexible benefits

Job summary

A leading global healthcare company is seeking an Advisor/Sr. Advisor - Inspection Lead to ensure inspection readiness and drive compliance initiatives in Indianapolis. This role involves leading the development of strategies, maintaining knowledge databases, and collaborating cross-functionally to improve inspection processes. A bachelor's degree and extensive experience in quality assurance within the pharmaceutical industry are required. Salary range is $121,500 - $198,000 with full-time employment and benefits.

Qualifications

• 7+ years of experience in the pharmaceutical or life sciences industry.
• Proven experience leading or supporting regulatory inspections.
• Strong knowledge of quality management systems.

Responsibilities

• Lead the development and execution of an inspection readiness strategy.
• Build and maintain the GISQ Inspection Readiness Knowledge Base.
• Identify and address gaps in inspection support processes.

Skills

Quality Assurance

Regulatory Compliance

IT Systems Validation

Cross-Functional Collaboration

Process Improvement

Education

Bachelor’s degree in a scientific, technical, or quality-related discipline

Advanced degree preferred

Tools

GxP regulations knowledge

Computer Systems Validation (CSV)

Job description

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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.

Join Lilly’s Global Information Systems Quality (GISQ) team as a GISQ Inspection Lead, where you will drive inspection readiness across GISQ and Tech@Lilly. In this role, you will establish a sustainable framework for proactive inspection support, knowledge management, and cross-functional collaboration. Your efforts will ensure that GISQ and Tech@Lilly are consistently prepared for regulatory inspections and that inspection-related knowledge is institutionalized and continuously improved. By maintaining Lilly’s high standards of compliance and operational excellence, you help safeguard patient safety, regulatory trust, and business agility.

You will partner with Tech@Lilly, Global Quality Compliance, Global Medical Quality Organization and others providing expert consultation and influence on Lilly’s computer system inspection readiness. This role provides high visibility across global functions and leadership, allowing you to influence the future of digital quality assurance at Lilly and collaborate with cross-functional quality and IT experts.

Be part of a mission-driven company improving lives worldwide.

Key Responsibilities

Inspection Readiness Strategy & Execution

• Lead the development and execution of a comprehensive inspection readiness strategy tailored to Tech@Lilly systems and operations.
• Establish virtual Inspection Team within GISQ to serve as the GISQ lead during inspections, ensuring timely and accurate responses to regulatory inquiries.
• Coordinate, support and lead mock inspections, readiness assessments, and real-time inspection activities.
  
  
  

Knowledge Management

• Build and maintain the GISQ Inspection Readiness Knowledge Base, including storyboards, FAQs, templates, and historical inspection data.
• Ensure the knowledge base is accessible, current, and aligned with evolving regulatory expectations.
• Facilitate training and onboarding sessions to embed inspection readiness culture across GISQ and Tech@Lilly.
• Collaborate with RCPMR (Regulatory Compliance and Post Market Reporting Team) team to utilize and maintain the global Regulatory Intelligence dashboard.
• Utilize external benchmarking to anticipate regulatory inspection needs and best practices for inspection support.
  
  
  

Cross-Functional Collaboration

• Partner with Tech@Lilly and Global Medicines Quality Organization (GMQO) inspection leads to align inspection processes, share best practices, and drive consistency.
• Collaborate with system owners, validation leads, and global and site quality representatives to ensure readiness is embedded in daily operations.
• Represent GISQ in global quality forums and inspection readiness working groups.
• Collaborate with RCPMR team to ensure Global Quality Systems (GQS) is aligned on inspectional support and remediation post inspection.
  
  
  

Process Improvement

• Identify and address gaps in inspection support processes.
• Lead continuous improvement initiatives to enhance inspection preparedness, reduce risk, and improve response agility.
• Identify and implement artificial intelligence and/ or automation of inspection readiness processes.
• Monitor regulatory trends and inspection outcomes to inform process enhancements.
• Active participation in After Action Reviews as appropriate and also to actively participate in the Preapproval Inspection/Pre-License inspection readiness process.
  
  
  

Success Criteria

To be successful in this role, the GISQ Inspection Lead will need to:

• Establish a centralized, user-friendly knowledge base utilizing technology that becomes the go-to resource for inspection readiness across GISQ and Tech@Lilly.
• Achieve a state of continuous readiness, demonstrated by successful mock inspections and minimal findings during actual inspections.
• -Foster strong partnerships with Tech@Lilly and Global Medical Quality Organization inspection leads, resulting in aligned processes and shared ownership of inspection outcomes.
• Drive measurable improvements in inspection response time, documentation quality, and stakeholder confidence.
• Demonstrate leadership and influence by embedding inspection readiness into the culture and daily practices of GISQ teams.
  
  
  

Basic Qualifications

• Bachelor’s degree in a scientific, technical, or quality-related discipline; advanced degree preferred.
• 7+ years of experience in quality assurance, regulatory compliance, or IT systems validation in the pharmaceutical or life sciences industry.
• Proven experience leading or supporting regulatory inspections (e.g., FDA, EMA).
• Strong knowledge of GxP regulations, computer system validation (CSV), and quality management systems.
  
  
  

Additional Preferences

• Understanding of process development and/or improvement (e.g. Six Sigma)
• Familiarity with IT Best Practices (e.g., LSEF, ITIL, NIST)
• Excellent communication, facilitation, and stakeholder engagement skills.
• Demonstrated ability to lead cross-functional initiatives and influence without authority.
• Demonstrated strong oral and written communication skills
• Strong interpersonal interaction skills
• Experienced with Computer Systems Validation/ Strong proficiency with IT systems development life cycle
• Ability to work independently and drive a diverse work-team
  
  
  

Other Information

• Located in Indianapolis, IN at Lilly Corporate Center
• May involve 5-10% travel
  
  
  

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 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 (for people with disabilities). 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

$121,500 - $198,000

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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