Eli Lilly and Company · 2 days ago
Advisor - PR&D Quality Systems
Indianapolis, IN
Full-time
Onsite
Director/Executive
$126K/yr - $205K/yr
10+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to making life better for people around the world. The PR&D Quality System Sr. Director provides critical technical leadership, ensuring compliance and continuous improvement of the PR&D Quality System while partnering with Global Process Owners.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Responsible for technical leadership of PR&D Quality System as it relates to early phases of clinical manufacturing and supply
Contribute to identifying and interpreting GxP requirements and other appropriate regulations that impact business processes
Influence and provide leadership within the broader PR&D organization when internal and external changes may influence the PR&D Quality System (QS) content and architecture
Providing phase appropriate guidance on quality topics that are discussed in CM&C teams or other governance forums
Communicating project information/quality issues to Quality Management supporting senior level review of the project (e.g, Spec Committee, DSM, etc.)
Mentor, coach and/or supervise other quality employees
Identify opportunities for and participate in continuous improvement and innovation efforts
Stay informed on external regulatory decisions that may impact PR&D and work with Quality and Regulatory to influence external agencies when needed
Work externally and cross functionally to understand best practices from a quality standpoint and implement change where needed while creating unique solutions to complex cross functional problems that ultimately supports innovation
Continually evaluate the state of compliance of the PR&D Quality System and influence senior management to drive improvement by proactively providing a solution
Lead/participate teams and projects focused on efforts to improve systems and processes
Support both internal and external audits
Actively seek internally and externally on expanding knowledge of applicable technology, regulations, and best practices that ultimately drive continuous quality improvements throughout PR&D and drive a quality mindset
Qualification
Required
Bachelor's degree in a scientific or medical related field or equivalent work experience
10-15 years of experience in development and clinical cgmp manufacturing and supply
Preferred
Demonstrated strong and effective written and verbal communication skills in multi-cultural and cross functional settings
Previous experience in Quality Assurance / Quality Control
Proven skill in leading change
Strong analytic skills
Recognized across functions as a subject matter expert
Able to collect data from multiple sources and create a clear narrative
Able to prioritise tasks efficiently to handle workloads from a combination of direct staff, indirect reports, and contractors at the PR&D site
Ability to build productive relationships and effectively communicate with senior leadership
Ability to work in an independent, flexible environment
Strong working knowledge of cGMP requirements and GCP regulations
Experience in Early Phase CT manufacturing
Strong knowledge of Early Phase CT Regulations
Experience/knowledge of oligonucleotides and antibody drug conjugate manufacturing, among others
Benefits
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
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