Sr. Principal Associate Quality Excellence and Inspection Readiness – Lilly Medicine Foundry

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.

Overview:

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 are looking for people who are determined to make life better for people around the world.

Organization and Position Overview:

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

The Sr. Principal Associate Quality Excellence and Inspection Readiness is responsible for partnering with the Compliance Leader to provide technical leadership to quality improvement and inspection readiness capabilities for the Foundry. The Sr. Principal Associate Quality Excellence and Inspection Readiness is responsible for the management and execution of site quality projects/initiatives focused on ensuring the site quality program is in accordance with regulatory and quality system requirements, and is ready for both self as well as internal inspections. The Sr. Principal Associate Quality Excellence and Inspection Readiness will partner with other internal Lilly Quality functions and/or sites to ensure the Foundry Quality Management processes and inspection readiness programs align with and satisfy current and future Lilly Quality standards and industry regulations, inclusive of innovation and flexibility for both Quality Management and Inspection Readiness.

Responsibilities:

• Support cross-functional teams, facilitate decision making, drive progress, establish key performance indicators for work area and monitor effectiveness.
• Act as a primary subject matter expert for Quality Excellence, potentially inclusive of:
  • Quality Continuous Improvement
  • Audits | Inspections
  • Quality Lead for Site Operational Excellence initiatives (initial focus on owning Inspection Readiness workstream for site operational readiness)
• Works in collaboration with the site quality leadership team, PR&D Quality staff, and global quality central teams to develop and manage the quality continuous improvement agenda.
• Establishes linkages with network and global teams and participate in relevant forums.
• Coach and train Quality teams in Lean tools and systems (for example, daily management, A3 thinking, standard work)
• Lead cross functional teams in the development and implementation of strategies associated with the area for the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Human Performance Reliability (HPR), etc.
• Prioritizes projects and initiatives with a focus on inspection readiness and in alignment with the main focus areas for the site.
• Establishes governance to provide oversight to the progress of the sanctioned projects.
• Ensures projects/initiatives have an approved charter, assigned team members, milestones, and due dates established.
• Keeps abreast of changes in the external environment to proactively assess and identify improvement opportunities.
• Ensures the successful implementation of quality-driven playbooks (e.g., Deviations Management Playbook, Inspection Readiness Playbook, etc.) at the site level:
  • Leads the deployment and implementation of the relevant playbooks at the site.
  • Works with the different functions to develop a deployment strategy and communication plan for the initiatives and ensures appropriate governance is in place.
  • Identifies key performance indicators to confirm the programs/initiatives, once implemented, are working as intended.
  • Ensures procedures, tools, and templates are in place (as applicable) for consistency and sustainability.
• Works in collaboration with the Compliance team to embed inspection readiness as part of the standard work.
• Ensure escalation of significant / critical quality problems to the appropriate levels of management following the standards set by the company. Follows the Notification to Management process.
• Supports activities to maintain the site in an adequate GMP inspection readiness state.
• Supports site inspections and internal audits as part of the backroom and/or front room team.
• Participates in the self GMP inspection program at the site.
• Drives a continuous improvement mindset across the organization.
• Effectively communicating with and managing internal and external stakeholders.
• Proactively managing issues, proposing, and implementing plans to resolve as needed.
• Promote a positive quality culture and oversee quality presence in the respective business areas (e.g. manufacturing, laboratories).

Basic Qualifications:

• BA/BS degree in Science, Engineering, or related field with a minimum of 5 years technical and/or quality experience in the Biopharmaceutical industry, preferably in a GMP manufacturing facility.
• Relevant industry experience in highly paced working environments. Relevant experience with performing quality continuous improvement processes.  Prior experience in Lean, Six Sigma, or Operational Excellence.
• Strong knowledge of current GMP expectations and application of quality management systems in execution.

Additional Preferences:

Demonstration of the following:

• Understanding of Quality Management processes, document control, and data integrity.
• Experience providing Quality Management process support for GMP manufacturing facilities.
• Flexibility to adjust quickly and effectively to frequent change and altered priorities.
• Ability to input and influence decision making for complex technical issues.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
• Ability to establish key relationships and influence peers and business partners.
• Strong communication skills.
• Ability to identify and prioritize issues, develop, and implement solutions.
• High learning agility and ability to deal with ambiguity, uncertainty.
• Capability to drive and design Key Performance Indicators (KPIs), metrics, and data analysis.
• Ability to identify through internal and external benchmarking opportunities to continuously improve and innovate quality

Other Information: 

• Initial location at Lilly Technology Center, Indianapolis.
• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. 

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

$63,000 - $162,800

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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