Associate Director, Quality Assurance -Sterile Manufacturing

Associate Director, Quality Assurance - Sterile Manufacturing

Manufacturing

Indianapolis, IN, US

Added - 12/12/2025

Pay: $140k-$160k

Schedule: 1 st shift

Type of Job: Direct Hire

Location: 100% On-site (Indianapolis area)

At this time, Astrix cannot transfer nor sponsor a work Visa for this position.

Relocation assistance is not available for this position.

Looking for a Pharmaceutical leadership role where you can shape quality operations, build strong teams, and influence the direction of a fast-growing organization? This opportunity is ideal for someone who thrives in startup or scale-up environments and enjoys creating structure, elevating standards, and driving continuous improvement.

• Responsible for the oversight of the QA teams responsible for supporting all production/processing areas.
• Leads investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation.
• Responsible for QA review and approval of Investigations, CAPAs, SOPs, Change Controls, and protocols/reports.
• Contributes in Regulatory/FDA inspections and audits by providing information or obtaining information required by the auditors.
• Performs review of root-cause analysis and ensures completeness, accuracy and compliance of all documentation.
• Develops and observes appropriate KPI's for batch documentation review and support of timely batch release.
• Accountable for the QA department planning, talent development, and budget administration.

• Bachelor’s Degree is required
• 6+ Years of progressive QA/QC experience
• 3+ years in a managerial role in a pharmaceutical or regulated industry

We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.