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Advisor - Deviation Management and Compliance, GMP Testing Laboratories

Employer
Eli Lilly and Company
Location
Indianapolis, Indiana
Start date
Feb 9, 2024

View more

Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest, Best Places to Work

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.

The Advisor-Deviation Management and Compliance responsibilities for the GMP laboratory areas within the BR&D Analytical Development Organization, which is focused on analytical method qualifications, validations, and transfers, as well as analytical release and stability testing for GMP drug substance, GMP drug product, and raw materials.
 

This role primarily supports deviation investigation writing and compliance process improvement for GMP laboratory areas in BR&D Analytical Development to ensure quality culture and quality system adherence in support of the pipeline portfolio. The individual will meet all objectives, facilitate on-time delivery of the portfolio, consult with business partners (both internal and external) on quality related matters, assist in monitoring quality metrics. Finally, this individual will collaborate with the local Quality System Team to maintain the quality system to overall regulatory and industry standards of compliance.

Responsibilities:
  • Lead investigations to determine root cause, corrective actions, ensuring the written report contains the technical merit and completeness according to regulatory expectations.

  • Mentors and guides deviation investigations and analytical investigators. Provide advice, review, and guidance to investigator team in deviation investigation and analytical investigations (assessment, quality impact evaluation, root cause analysis method), investigation write-up (technical writing), support data, etc.

  • Operate cross-functionally, collecting and analyzing necessary data and information associated with the manufacturing and laboratory investigations and determine the meaningful corrective action to prevent the deviation from reoccurring.

  • Lead and manage the deviation review board meetings. Immediately upon assignment of an investigation, partners with their investigation team (QA Reviewer/ Approver, SMEs [subject matter experts], and necessary stakeholders) on definition and alignment of the investigation plan, required data, and timing for completion. 

  • Facilitates the investigation / CAPA team to define objectives, deliverables, ownership, due dates, and effectiveness requirements; Ensures smooth transition of the defined CAPA to the owning department SME and ensures the CAPA progresses to implementation timely.

Basic Qualifications:
  • PhD. in Science or Engineering with industry experience in Analytical development, product and process development, quality assurance, or technical services in pharmaceutical or other regulated industries

    OR

  • Bachelor’s degree in relevant Science or Engineering discipline and/or equivalent combination of work experience is required.

  •  10+ years of relevant experience

Additional Preferences:
  • Deviations or Investigation experience

  • CAPA experience

  • Data Integrity knowledge and experience

Additional Information:
  • 0-10% travel required.

  • Position requires 8 hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc.

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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