Senior Director Regulatory Affairs Jobs in Wisconsin

INTRODUCTION

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 AND RESPONSIBILITIES

The Engineering Sr. Director, Site Expansion role is a critical role to ensure we continue to make progress towards our mission and our culture. This role will play a critical role in leading the seamless integration of a large site expansion project into the site commercial operation focusing on operational readiness.

Project delivery and readiness

- Deliver engineering support for major expansion project partnering with Lilly Global Project Delivery team to drive efficiency, organizational integration and operational readiness of project integration into the Parenteral manufacturing network
- Ensure thorough and meaningful measurement and analytics on key questions, business needs and delivery of key project milestones to help drive the business and better serve our customers
- Support site annual strategic planning and business plan processes, ensuring project needs including resources are planned and supported
- Lead and manage operational readiness of major expansion project
- Building engineering capabilities for site expansion including planning, hiring and onboarding of internal and external resources
- Partner closely with Engineering leader at the site to ensure alignment between ongoing operations and project needs

Drive Operational Excellence and Project Management alignment

- Lead and facilitate key project meetings and ensure follow up on actions and inform stakeholders
- Anticipate and facilitate the resolution of issues that impact key project deliverables
- Ensure appropriate governance in place to ensure safety, quality, agility and execution to drive most important work
- Monitor the progress on project milestones and collaborate with site project management function ensuring alignment on LKC integrated project schedule and take action to escalate/remove barriers
- Support site to facilitate consistent processes and efficient planning

Effective Communication

- Drive connectivity between sites, functions and networks to ensure alignment of strategic objectives, planning and execution
- Establish and manage documentation and communication of key decisions, actions, and key modifications in time, budget, scope, and risks to key stakeholders
- Influences senior management, internal and external customers to ensure effective stakeholder management

BASIC QUALIFICATIONS

- Bachelor’s degree in engineering
- 10+ Engineering experience in a parenteral manufacturing site
- Experience from onboarding and/or executing larger capital projects
- Previous facility or area start up experience
- Prior management or leadership experience including leading or working effectively with a cross functional group including network and/or global functions
- Excellent interpersonal, written, and oral communication skills
- Strong technical aptitude and ability to train and mentor others
- Ability to handle multiple competing priorities

PREFERRED QUALIFICATIONS

- Solid understanding of basic requirements of regulatory agencies
- Previous experience with parenteral engineering/manufacturing
- Previous experience with highly automated equipment
- Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
- Previous equipment qualification and process validation experience
- Previous experience with Manufacturing Execution Systems and electronic batch release
- Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs
- Previous experience with deviation and change management systems including Trackwise

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 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 $147,000 - $215,600.

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.