Validation Lead

Eli Lilly and Company • Indianapolis, IN

23h

About The Position

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. The Global MQ Tech@Lilly Labs group is a central group designing, validating, supporting and providing consultancy over the systems in scope. Within this function, the Validation Lead is principally tasked with ensuring the Global Labs organization is fully compliant with all government regulations and corporate policies and procedures for the system/s within scope. To achieve full compliance, this role reviews the implementation plans for quality and compliance initiatives that identify, escalate, and mitigate risks within Global Tech@Lilly Labs. The position is responsible for ensuring that all solutions deployed are developed and implemented according to corporate policies and regulatory requirements. The role has oversight of computer systems validation activities, including the approval of all documentation issued to support the validation/qualification of non-GMP and GMP systems within the scope of the position, as appropriate.

Requirements

• Bachelor of Science degree in IT, Engineering, or related field
• 6+ years of experience in FDA-regulated industry in a Quality Assurance, Compliance or Computer Systems Validations role, leading and managing qualification efforts for GMP relevant applications.
• 5+ years of experience working in support of manufacturing and quality information processes and systems in an FDA-regulated industry, with a focus on Process Automation, Logistics, or Lab systems, including LIMS platforms such as LabVantage, LabWare, Empower, SAP, Moda, or comparable systems.
• Experience and knowledge with FDA regulations as they pertain to information and digital solutions, including 21 CFR Part 11 and GMP compliance requirements, with experience supporting validation strategy for regulatory inspections.
• Experience applying risk-based approach to system validation in FDA-regulated environments.
• Prior experience developing and executing computer system validation documentation, including validation plans, protocols, and reports.
• Experience developing and maintaining standard operating procedures supporting validated systems.
• 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

• Experience with leading technology delivery projects, from inception through delivery and post-production support, of manufacturing and quality information and digital solutions (processes and systems) in an FDA-regulated industry.
• Knowledge on Pharmaceutical regulations (e.g. cGMP’s, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.).
• Collaboration with colleagues at all levels to ensure integration and results.
• Excellent written and verbal communication skills.
• Demonstrated success in influencing without authority, results oriented.
• Demonstrated learning agility.
• Highly flexible, while anticipating, embracing and adapting to changes in priorities, requirements and processes is required.
• Ability to work independently, and on multiple concurrent project initiatives.
• Must be self-motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.

Responsibilities

• Provide guidance and oversight of computer systems quality and compliance activities, including the review and approval of computer systems validation deliverables as appropriate.
• Respond to and manage Global Tech@Lilly Labs related audit activities.
• Provide assistance in developing responses to external and internal audit findings and managing execution and on-time completion of all mitigation activities.
• Execute local processes to ensure that information and digital solutions are implemented and maintained according to corporate policies and regulatory requirements (i.e.: 21 CFR Part 11, GMP), including data privacy.
• Collect, evaluate and prioritize opportunities to improve compliance and privacy related policies and procedures.
• Report, analyze, audit and develop plans and programs to support continuous quality improvement.
• Manage the relationship between Tech@Lilly and other cross-functional groups and organizations that involve QA, compliance, privacy, and system validation practices.
• Leverage relationships to effectively enhance corporate and IT initiatives for these areas to support the delivery of results for the enterprise through teamwork.
• Help determine the GMP designation and testing requirements for analytics tools.
• Must have working understanding of compatibility, integration, interoperability, stability, scalability and usability of products/services being implemented to ensure validation activities cover all requirements.
• Must ensure security and privacy risks are considered in the design and testing of IT systems.

Benefits

• 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).

What This Job Offers

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