Job Description

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.

Pay: $140k-$160k

Schedule: 1st 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.

Associate Director, Quality & Compliance: Daily Tasks : What you will do:

• 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.

Associate Director, Quality & Compliance Qualifications/Requirements:

• 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!

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