Associate Director, Quality Assurance

3 days ago

Lebanon, Indiana, United States Eli Lilly Full time

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.

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in 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, 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 start up the facility for both clinical and commercial supply.

Job Position Overview:

The QA Associate Director is responsible for providing leadership and daily support and oversight to Site delivery/startup and GMP operation of the Lilly Advanced Therapies Site (LP2). The Associate Director is also responsible for managing the activities of Quality Assurance personnel with respect to GMP oversight, regulatory requirements, procedural interpretation and training, regulatory agency inspections and maintenance of inspection readiness. This role may also support external manufacturing (EM) responsibilities, which includes collaboration partner oversight and lifecycle management.

Responsibilities:

  • Provides QA leadership to a team responsible for the startup of a new facility specializing in advanced therapies, e.g. gene therapies (SF9 and HEK platforms), Lipid nanoparticle (LNP, etc) and associated quality systems. Once active, support operational excellence initiatives and day-to-day.
  • Build out and lifecycle manage new acquisitions and collaboration partners for our advance therapies team, which includes manufacturing oversight, person-in-plant, quality agreements, deviation and change management, and batch release, as needed.
  • Maintain a safe work environment; actively support all HSE Site safety goals/initiatives
  • Foster a quality culture that promotes open communication, participation and teamwork
  • Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment

Basic Requirements:

  • Bachelor's degree in a science, engineering, pharmaceutical-related field of study or equivalent experience.
  • 5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group.

Additional Skills/Preferences:

  • Strong knowledge of Quality Management Systems, Site Compliance processes, and regulatory requirements (e.g., CFRs, EU, ISO)
  • Excellent interpersonal, written and oral communication skills
  • Strong technical aptitude and ability to train and mentor others
  • Strong self-management and organizational skills, ability to prioritize
  • Demonstrated problem-solving and decision-making skills
  • Previous regulatory inspection readiness and inspection execution experience
  • Regulatory inspection readiness and management experience
  • Experience in Advanced Therapies platforms, e.g. Gene Therapy, LNP, etc.
  • Previous facility or area start up experience
  • Proficiency with industry systems including Kneat, Veeva Vault, SAP, manufacturing execution systems, and Microsoft Office product

Additional Information:

  • Position Location: US: Lebanon IN LP2
  • Travel Percentage (%): Position may require travel (10-25%)
  • Shift Information: core work is first shift, ability to work 8-10 hour days – Monday through Friday at the Lebanon, Indiana Advanced therapies site. Role is considered on-site, non-remote.

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

$123,000 - $180,400

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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