- GRAIL (Indianapolis, IN)
- …with internal teams to implement appropriate changes. + Support internal and external quality audits. + Ensure compliance with all regulations and laws ... and other relevant documentation. The role collaborates cross-functionally with Quality , Lab Operations, and other stakeholders to support regulatory strategy… more
- Parexel (Indianapolis, IN)
- …associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading ... other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study...data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality… more
- Parexel (Indianapolis, IN)
- …associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading ... other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study...data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality… more
- Parexel (Indianapolis, IN)
- …to safeguard the quality of investigator sites (eg patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site...clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws,… more
- Astrix Technology (Indianapolis, IN)
- ** Associate Director , Quality & Compliance ** Quality Assurance Indianapolis, IN, US + Added - 15/12/2025 Apply for Job Associate Director , ... Quality & Compliance , you will **own GMP quality execution** for a commercial-scale sterile facility, build and scale QA/QC capabilities, and drive inspection… more
- Astrix Technology (Indianapolis, IN)
- …for this position. Relocation assistance is not available for this position. ** Associate Director , Quality & Compliance : Daily Tasks** : What you will ... department planning, talent development, and budget administration. ** Associate Director , Quality & Compliance Qualifications/Requirements:** +… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Job Summary** The Associate Director , Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial ... way that is in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role will direct Biologics Quality Assurance support,… more
- Lilly (Lebanon, IN)
- …facility for both clinical and commercial supply. **Job Position Overview:** The QA Associate Director is responsible for providing leadership and daily support ... Site delivery/startup and GMP operation of the Lilly Advanced Therapies Site (LP2). The Associate Director is also responsible for managing the activities of … more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's ... and compliance of external manufacturing partners to ensure the quality and reliability of pharmaceutical products, including small molecules and biologics.… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- **Job Summary** The Associate Director , Global Product Quality - GMP Process is responsible for enabling the optimization and harmonization of key GMP ... and subject matter expertise to global teams on GMP compliance and quality system execution. **Qualifications** Required + Bachelor's degree in Pharmacy,… more
