Leading Biotechnology Research company is hiring for an Associate Director of Quality Assurance to oversee quality systems within GMP manufacturing of pharmaceuticals. Exciting opportunity to work with a biotech company that is leading the way in transformative nuclear medicine for oncology research!

Location: Indianapolis, IN

Salary: $150K-$180K (not including annual bonus!)

Employment Type: Direct Hire

Responsibilities

• Provide daily leadership and oversight to QA teams supporting all production and processing areas.
• Develop and monitor Key Performance Indicators (KPIs) for batch documentation review, Right First Time (RFT) metrics, and efficient batch release timelines.
• Manage department resources, including personnel development, talent management, and budget administration for the QA team.
• Lead investigations into product complaints and manufacturing discrepancies, ensuring that all necessary documentation is completed thoroughly and accurately.
• Review root cause analyses and problem-solving initiatives to identify and implement effective corrective and preventative actions, as well as appropriate effectiveness checks.
• Review and approve key quality documentation such as Investigations, CAPAs, Standard Operating Procedures (SOPs), Change Controls, and protocols/reports.
• Ensure the completeness, accuracy, and compliance of all quality-related documentation, including the preparation and review of Annual Product Quality Reports and relevant KPIs/metrics.
• Actively participate in regulatory audits and inspections (including FDA), providing necessary information and assisting in obtaining any additional documentation required by auditors/inspectors.
• Plan and conduct pre-inspection reviews of operations, ensuring that corrective actions are implemented where needed.

Qualifications

• Bachelor’s degree required
• A minimum of 6 years of progressive experience in QA/QC within a regulated industry, including at least 3 years in a management or leadership position.
• Experience with sterile injectables and GMP manufacturing of pharmaceuticals