Associate Vice President - Visual Inspection SME - MSAT jobs in United States
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Eli Lilly and Company · 4 days ago

Associate Vice President - Visual Inspection SME - MSAT

Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on discovering and delivering life-changing medicines. The Associate Vice President for Visual Inspection will lead the visual inspection team and develop standards for parenteral pharmaceutical products, ensuring compliance with regulatory requirements and driving quality outcomes.

BiotechnologyHealth CareMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Lead the design, development, and implementation of visual inspection standards for parenteral products, ensuring compliance with regulatory requirements and industry best practices
Build the organization for success; Recruit strong talent with the right capabilities, effectively manage performance to elevate team member contributions, and foster a culture of innovation, inclusion, and respect for people
Evaluate and validate visual inspection processes, including both manual and automated inspection methods, to achieve optimal quality outcomes
Establish risk-based inspection strategies for different types of parenteral products and materials (e.g., vials, syringes)
Harmonize visual inspection control strategies and practices across the internal and external manufacturing network
Serve as the go-to expert on visual inspection processes, equipment, and quality standards for the parenteral product lines
Conduct root cause analyses and implement corrective and preventive actions (CAPAs) for quality related events
Collaborate with cross-functional teams to identify and implement process improvements that enhance efficiency and reduce inspection errors
Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection processes and documentation up-to-date
Participate in internal and external audits, providing expert insights and support for any inspection-related findings
Act as subject matter expert for the development and maintenance of internal strategy documents and execution documents (validation reports, etc.) to support the visual inspection programs
Explore and evaluate new technologies and methodologies in visual inspection, including AI, to enhance accuracy and efficiency
Identify opportunities for process automation, working closely with engineering teams to implement new tools and technologies

Qualification

Visual Inspection ExpertiseRegulatory Compliance KnowledgeProcess OptimizationTraining Program DevelopmentAnalytical SkillsAutomated Inspection SystemsPeople LeadershipInnovation MindsetProblem-Solving SkillsAttention to Detail

Required

Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related field
15+ years of experience in visual inspection for injectable pharmaceutical products in a GMP-regulated environment
In-depth knowledge of visual inspection standards, practices, and equipment specific to parenteral products
Familiarity with regulatory guidelines (FDA, EMA, ICH) and experience with regulatory inspections
Proven track record of developing training programs and mentoring inspection teams
Strong analytical and problem-solving skills, with attention to detail and a commitment to quality

Preferred

Advanced degree preferred
Experience with automated inspection systems and/or artificial intelligence for quality control is a plus

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

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We're a medicine company turning science into healing to make life better for people around the world.

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 Company
Total Funding
$6.5M
2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO

Leadership Team

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David Ricks
Chair, CEO
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Lucas Montarce
Executive Vice President and Chief Financial Officer
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Company data provided by crunchbase