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

Eli Lilly • Lebanon, IN

115d • $63,000 - $162,800

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 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.

Requirements

• 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.

Nice To Haves

• 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.

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).
• Work 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.
• Establish 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 Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Human Performance Reliability (HPR), etc.
• Prioritize projects and initiatives with a focus on inspection readiness and in alignment with the main focus areas for the site.
• Establish governance to provide oversight to the progress of the sanctioned projects.
• Ensure projects/initiatives have an approved charter, assigned team members, milestones, and due dates established.
• Keep abreast of changes in the external environment to proactively assess and identify improvement opportunities.
• Ensure the successful implementation of quality-driven playbooks (e.g., Deviations Management Playbook, Inspection Readiness Playbook, etc.) at the site level.
• Lead the deployment and implementation of the relevant playbooks at the site.
• Work with the different functions to develop a deployment strategy and communication plan for the initiatives and ensure appropriate governance is in place.
• Identify key performance indicators to confirm the programs/initiatives, once implemented, are working as intended.
• Ensure procedures, tools, and templates are in place (as applicable) for consistency and sustainability.
• Work 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.
• Support activities to maintain the site in an adequate GMP inspection readiness state.
• Support site inspections and internal audits as part of the backroom and/or front room team.
• Participate in the self GMP inspection program at the site.
• Drive a continuous improvement mindset across the organization.
• Effectively communicate with and manage internal and external stakeholders.
• Proactively manage 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).

Benefits

• 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.
• 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
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree