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Commercialization QA Lead - Drug Product External Manufacturing

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Feb 23, 2024

Job Details

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:

Drug Product External Manufacturing (DPEM) Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight of contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations and termination. DPEM Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

The Quality Assurance Commercialization Lead is primarily responsible for QA oversight for commercialization of the parenteral product portfolio within DPEM.  The QA Lead will represent DPEM QA on the CMC teams, providing oversight for technology transfers, process validations, regulatory submissions, Response to Questions and launch of new products from DPEM Contract Manufacturers.

Responsibilities:

Key Objectives/Deliverables:

  • Works with DPEM management and TS/MS to develop and facilitate the site's commercialization mission by enabling introduction of new products, NILEX (new line extensions) within DPEM Contract Manufacturers.
  • Provides Quality oversight of commercialization deliverables (e.g., technology transfers, product control strategies, process validations, regulatory submissions, Response-to-Questions, launch plan, etc.) to ensure smooth progression of products through the commercial pipeline.
  • QA support for the development and oversight of the Manufacturing Control Strategy.
  • Development of relationships with Contract Manufacturing peers to drive effective communication.
  • Ensures quality operational readiness to meet aggressive product launch timelines according to the single process map and commercialization model.
  • Participates in product development reviews to ensure appropriate design for manufacturability.
  • Pre-Approval Inspection Readiness support
  • The QA Lead – Commercialization has authority to approve DPEM documents that procedurally require quality approval at the Assoc Director level: deviations, change controls, technical documents, risk assessments, etc.
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and site goals.

Product and DPEM Support:

  • Participate in the creation and revision of standard operating procedures
  • Work with Lilly support groups to resolve product related issues
  • Participate on Commercialization transition to Joint Process Teams
  • Be involved with Lean/Continuous Improvement projects to help improve productivity

Basic Requirements:

  • BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences or equivalent experience
  • Minimum 7 years of experience in pharmaceutical manufacturing and/or related areas

Additional Preferences:

  • Experience in Lilly electronic quality systems (Trackwise, Veeva)
  • Technical knowledge of pharmaceutical manufacturing
  • Coaching and mentoring skills
  • Previous demonstration of strong leadership skills.
  • Strong interpersonal and communication skills.
  • Demonstrated problem solving skills and a broad knowledge of Parenteral operations, quality systems, and global quality standards.
  • Experience working with development quality system, biotech product regulations, ICH requirements, and product commercialization.
  • In addition, the candidate must possess a solid understanding of the importance of Regulatory agencies such as the FDA and EMA, particularly in the area of cGMPs.
  • Demonstrated solid judgment and initiative.

Other Information:

  • Shift is days, but off-hours may be necessary to support operations
  • Some travel is possible (<20%)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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