What are the responsibilities and job description for the Associate Director Quality Assurance position at Astrix?
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!
Salary : $140,000 - $160,000