Associate Director of Quality Control

3 days ago

Lebanon, Indiana, United States Eli Lilly Full time
Job Title: Associate Director of Quality Control

Lilly is seeking an experienced Associate Director of Quality Control to join our team in Lebanon, IN. As a key member of our Quality Control team, you will be responsible for providing technical leadership and expertise in the development, performance, and maintenance of our Chromatography Lab.

Key Responsibilities:
  • Provide technical leadership and performance management of staff
  • Maintain a safe work environment and ensure GMP compliance
  • Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, and annual product reviews
  • Partner with Quality Control and functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
  • Interact with regulators, customers, and other stakeholders on business issues or in support of internal and external agency audits
  • Ensure adequate oversight and technical excellence for investigations and complaints
  • Collaborate with the QC team to develop the strategy for the technical agenda to improve process control, yield, efficiency, and productivity for all products within the site portfolio
  • Provide oversight for technical projects to improve process control, capacity, yield, and quality
  • Ensure adequate technical representation and engagement within the site and network governance meetings to influence technical agendas
  • Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites
  • Engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization
Requirements:
  • Bachelor's Degree in a scientific discipline, such as Chemistry, Biochemistry, Biology, Pharmaceutical Science, or Engineering
  • 5+ years of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment
  • Extensive knowledge of various chromatographic methods and related analytical techniques
Preferred Qualifications:
  • Ability to influence and lead diverse groups
  • Experience with complex regulatory, business, or technical issues for pharmaceutical manufacturing
  • Strong analytical and quantitative problem-solving skills
  • Experience with Empower software and LIMS implementation
  • Experience with statistical analysis of data
  • Technical leadership, administrative, and organizational skills
  • Proficiency in delivering complex tasks and/or tasks that are highly cross-functional
  • Ability to communicate and influence effectively across functional groups and stakeholders
  • Strategic thinking and ability to balance short-term needs with long-term business evolution
  • Ability to build relationships with internal and external customers and partners
  • Enthusiasm for change, team spirit, and flexibility
  • Demonstrated ability to learn and apply technical/scientific knowledge
Additional Information:

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 offer strong support networks for their members and help our company develop talented individuals for future leadership roles.

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