Quality Assurance - LP2 CSQA and Data Lead

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Organization Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. At Lebanon, Indiana, this facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission, start up, and maintain the facility for both clinical and commercial supply.  This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up. 

The Associate Director, Quality Assurance - Computer Systems & Data Leader, will initially serve as the Computer Systems Quality Assurance Lead for the design and start-up phases for the new new facility in Lebanon, Indiana, with primary focus on the manufacture of Advanced Therapeutic Medicinal Products (ATMPs) such as gene therapies. This role is responsible for QA technical oversight including approvals, cross-functional decision making and site level mentoring for CSQA staff. The CSQA Lead will be responsible for training and mentorship of the quality assurance group supporting computer systems, operational data control, and inspectional readiness. Additionally, this role will ensure data integrity strategies are built and maintained across the site. There is a strong focus on integration of systems both IT, automation and laboratory to ensure GMP data controls. This role will partner with a network of global Data Management Leaders across existing sites to foster a strong quality culture and lead site strategies for data integrity integration, assessment and monitoring. 
Responsibilities:

Act as the computer systems validation (CSV) quality assurance project lead, working with Global Facility Delivery and Lilly project staff to complete the detailed design. Design vision includes employing QbD (Quality by Design) and QRM (Quality Risk Management) principals, ensuring data integrity by design and compliantly integrating Global Quality System requirements.  

Consult with Network and Global quality groups including the Global Quality Systems, Information Systems Quality, and Global Data Management as required to ensure consistent and compliant approach is executed during the project, startup phase and designed for sustainability during routine production.

• Provide technical and quality review and approval of project computer system documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures, including review of test cases, test execution, discrepancy resolution, etc.  

• Work with the Associate Director, Quality - Compliance, to support the development of the vision and strategy for the overall site quality operation with focus on the CSQA and Data Management topics 

• Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring of new Quality and other project staff 

• Lead project initiatives needed in support of the project and Quality function 

• Resolve or escalate any compliance issues to the project, site, and Quality Management 

• Participate in self-led inspections and provide support during internal/external regulatory inspections

• Leverage technology to ensure data digitalization and standardization where appropriate

• Design, replicate and employ analytics and advanced analytics for competitive advantage within the site

Basic Requirements:

• Bachelor's degree in engineering or computers preferred; Science-related field will be considered

• 5+ years working in the pharmaceutical or medical device industry in QA roles 

• 3+ years of experience in Computer System Quality Assurance/Computer System Validation

• 3+ years of experience with data analytics including advanced analytics

• 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.

Additional Skills/Preferences:

• Demonstrated proficiency with GMP computer systems validation including regulations governing them

• Demonstrated knowledge and application of data integrity regulatory guidance

• Proven ability to apply analytics and advanced analytics for competitive advantage within a manufacturing operation 

• Demonstrated strong oral and written communication

• Demonstrated strong interpersonal interaction skills and ability to influence cross-functional organizations

• Demonstrated strong technical writing skills 

• Demonstrated 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) - preferable

Additional Information:

• Ability to work 8-hour days – Monday through Friday 

• During the project phase, this position will allow for a flexible working environment with the ability to periodically work remotely based on the scope and nature of the activities 

• Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish specific computer system validation and/or data integrity knowledge 

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

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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