Sr. Manager QA Batch Disposition

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.

Organization Overview:
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site.  The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!

Responsibilities:
The Quality Assurance Batch Disposition Team assures patients worldwide of safe and efficacious drug and device products, through effective quality oversight of site activities. The Senior Manager QA Batch Disposition will lead the team responsible for disposition of intermediates, semi-finished and/or Finished drug combination products. The Senior Manager QA Batch disposition will be responsible for cross functional decision making and ensuring batches are released per schedule. The Senior Manager QA Batch Disposition will be trained on batch disposition processes and be responsible for training their team.

• Support the site in the development and execution of the site readiness plan with focus on supporting development of the site e-release process and startup of new systems

• Support recruiting, build capability, for a diverse leadership and quality assurance staff to support and train personnel on batch disposition processes.

• Performs final batch disposition of intermediates, semi-finished and/or finished drug product and combination product batches, to ensure high quality medicine (GMP Compliance) is released to market in a timely manner

• Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls)

• Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment 

Basic Requirements:

• 5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group

• ​Previous batch disposition experience

• Ability to make technical decisions, provide guidance to the site

• Proficiency with applicable computer systems

• Demonstrated strong oral and written communication skills

• Demonstrated interpersonal skills and the ability to work as a team

• Root cause analysis/troubleshooting skills

• Demonstrated attention to detail and ability to maintain quality systems

• Previous regulatory inspection readiness and inspection execution experience

• Commit to successfully maintain Lilly Computer System Quality Assurance (CSQA) Certification

• Ability to travel up to 10% for meetings and coordination with global or existing manufacturing sites

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals

Additional Skills/Preferences:

• Proficiency with SAP, MES, and Trackwise

• Root cause analysis/troubleshooting skills 

• Previous regulatory inspection readiness and inspection execution experience