Associate Director Quality Assurance; pharma

Associate Director Quality Assurance (pharma)

Quality Assurance

Indianapolis, IN, US

• Added - 18/12/2025

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Pay Rate Low: 140000 | Pay Rate High: 160000

Our client within the pharmaceutical industry is seeking a quality assurance professional to join their team! This a fast-growing organization seeking someone who can be successful working in a start-up/scale-up environment.

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.

• 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 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.