Senior Director, External QC & Stability - Remote

BioSpace; Indianapolis (IN); Remote; USD 117,000 - 260,000; Full time

Job summary

Lilly, headquartered in Indianapolis, is seeking a Director, External Quality Control & Stability, to lead analytical quality oversight across programs. This remote US role offers the chance to drive regulatory-compliant stability activities and supplier oversight in a fast-paced environment.

You will review methods, support transfers, and guide stability strategy, partnering with cross-functional teams to ensure product quality and timely submissions.

Qualifications

• BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.
• 10+ years quality control and analytical development experience.
• Experience developing strategic vision with tactical support for QC programs.

Responsibilities

• Analytical oversight and tactical support across multiple programs.
• Review analytical methods, specifications, and validation activities.
• Support analytical method transfer as required.
• Collaborate on supplier qualification and remediation activities.
• Oversee the stability program design and execution.
• Ensure regulatory compliance of stability activities.
• Provide regulatory support for submissions and inspections.
• Review analytical and stability sections within CMC filings.

Skills

Quality control leadership

Analytical development

Regulatory submission support

Supplier oversight

Program oversight

Education

BS/MS/PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field

Job description

Lilly, headquartered in Indianapolis, is seeking a Director, External Quality Control & Stability, to lead analytical quality oversight across programs. This remote US role offers the chance to drive regulatory-compliant stability activities and supplier oversight in a fast-paced environment.

You will review methods, support transfers, and guide stability strategy, partnering with cross-functional teams to ensure product quality and timely submissions.