Associate Director - Computer System Validation Lead

Location: Indianapolis

Associate Director - Computer System Validation Lead page is loaded## Associate Director - Computer System Validation Lead locations:
US, Indianapolis INtime type:
Full time posted on:
Posted Yesterday job requisition :
R-99713

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.
** This is an opportunity you don’t want to miss!
** Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing to create a new state-of-the-art manufacturing sites. The brand-new facilities will utilize the latest technology for API Manufacturing and will include several platforms including Peptides, Small Molecules and Oligonucleotides Drug Substance Manufacturing. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site.  

The sites will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.
** What You’ll Be Doing**:

You will be part of Tech at Lilly MQ (Manufacturing and Quality), an organization that drives manufacturing operational excellence and productivity efforts through utilization of technology. Tech at Lilly MQ strives to enable the making of medicine “with safety first and quality always”.The Business Integration CSV Lead will provide technical leadership across the different site and global IT groups focused on Computer System Validation Strategies, external regulations, industry best practices, policies and procedures governing the process to validate, maintain and retire new and existing computer systems.  

This role will be responsible for managing and maintaining the process architecture of global strategies, policies and procedures to ensure that all solutions deployed are developed and implemented according to corporate policies and regulatory requirements.

This role will collaborate within the Lilly Tech at Lilly and Quality organizations and externally with industry forums and standard to ensure the state of compliance of computer systems. This position is vital for ensuring all programs are aligned with the overall Strategy for New API facilities and deliver desired outcomes efficiently and within budget.
** How You’ll Succeed:
*** Oversight of computer systems validation strategies and activities across new API facilities, including the review and approval of all documentation issued to support the validation/qualification of non-GMP and GMP systems, as appropriate.
* Define the risk management approach to be followed by new API facilities.
* Define the inspection readiness approach for new API facilities.
* Acts as the primary contact and has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy initiatives to ensure that all computer-based systems comply with internal and external privacy policies and requirements.
* Support Data Integrity readiness for regulatory authority inspections and if required, effectively represent the company during regulatory audits through interaction/ discussion with regulatory officials related to data management and integrity.
* Ensure we have consistent and reusable CSV strategies and artifacts across all New API facilities.
* Participate in business plan activities and in appropriate site governance and steering teams.
* Create a standard approach for GMP designation and testing requirements for site systems.
* Must have working understanding of compatibility, integration,…