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Sr. Director, Quality Assurance - Digital Transformation

BioSpace
Indianapolis, IN Full Time
POSTED ON 4/17/2025 CLOSED ON 4/24/2025

What are the responsibilities and job description for the Sr. Director, Quality Assurance - Digital Transformation position at BioSpace?

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.

Role Title: Sr. Director, Quality Assurance - Digital Transformation

Position Summary

The Digital Transformation Lead, Quality Assurance, will support the start-up and operation of the QA organization overseeing Digital Transformation for the Global API Network Expansion manufacturing sites. This role is responsible for providing technical and administrative leadership, project management, and strategic oversight to ensure the successful implementation of digital initiatives that enhance quality, compliance, and operational efficiency.

Key Responsibilities

Digital Strategy & Consulting

  • Serve as a digital consultant embedded in site strategic initiatives, collaborating with TECH@LILLY and site stakeholders to develop a digital plant vision and execution roadmap.
  • Influence site leadership on digital strategy, ensuring technology is leveraged as an enabler for strategic initiatives.
  • Provide input into business plans and site strategic exercises to drive progress on digital transformation.


Business Analysis & Digital Integration

  • Develop an in-depth understanding of business processes at Kinsale and other API sites to identify and implement digital solutions that maximize business value.
  • Enhance digital literacy across the site to drive ongoing support and innovation in technology adoption.
  • Actively network with MQ TECH@LILLY resources to share initiatives, promote best practices, and champion reusable solutions.


Technical Leadership & System Integration

  • Evaluate user requests and apply technical and process expertise to determine true business needs.
  • Collaborate with developers and subject matter experts to establish a technical vision, balancing usability and performance requirements.
  • Lead the development and integration of IT solutions that support systems and business processes.
  • Benchmark and stay informed of emerging technologies and innovative solutions.


Project Leadership & Execution

  • Partner with TECH@LILLY and business area management to secure funding for prioritized digital plant projects.
  • Develop and update project plans, defining key activities and milestones.
  • Oversee the execution of Digital Plant projects (e.g., MES implementation) to ensure adherence to budget, schedule, and scope.
  • Provide ongoing communication on project status, key issues, and deliverables to management and staff.
  • Manage multiple projects simultaneously across various job functions.


Resource & Team Development

  • Work with TECH@LILLY and Automation management to develop a resource plan and structure to support digital transformation initiatives.
  • Oversee activities of contractors and employees, ensuring alignment with project goals.
  • Build and lead a high-performing team, fostering a culture of technical excellence, accountability, and leadership.
  • Promote a safe and environmentally responsible workplace, minimizing operational risks.


Basic Requirements

  • Bachelor’s degree in science, engineering, pharmaceutical-related field, or equivalent experience.
  • 10 years of pharmaceutical leadership experience with a focus on Digital Transformation and Quality Assurance.


Preferred Qualifications

  • Ability to maintain Lilly Computer System Quality Assurance (CSQA) Certification.
  • Strong knowledge of Quality Management Systems and regulatory requirements.
  • Experience in materials management and supplier governance.
  • Familiarity with computer systems such as SAP, Veeva QDocs, and TrackWise.
  • Excellent interpersonal, written, and oral communication skills.
  • Strong technical aptitude with experience mentoring and training teams.
  • Proven problem-solving and decision-making abilities.
  • Experience with facility start-ups, equipment qualification, and process validation.
  • Regulatory inspection readiness and execution experience.


Other Information

  • This role may require travel, up to 30%, to support global site implementations and supplier engagements.
  • Job responsibilities may evolve based on business needs, and updates will be made accordingly.


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

$151,500 - $222,200

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.

#WeAreLilly

Salary : $151,500 - $222,200

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Sr. Director, Quality Assurance – Materials Management & Logistics
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