**Associate Director of Quality Assurance** Manufacturing Indianapolis, IN, US Pay Rate Low: 150,000 | Pay Rate High: 180,000 + Added - 16/01/2025 Apply for Job **_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 INDBH \#LI-DNP 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.