- 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)
- …quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) ... with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential… more
- Parexel (Indianapolis, IN)
- …quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) ... with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential… 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 ... sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- The Director , Quality & Compliance Training , is a senior leader within the Learning Center of Excellence under Global Quality . This role is ... objectives and quality principles. + Establish governance frameworks for training compliance and operational excellence, including policies and SOPs. +… more
- Lilly (Indianapolis, IN)
- …Small Molecules, Large Molecule and Peptide APIs at external manufacturing facilities globally. The Sr. Director - Quality - Small Molecule API EM is the Site ... improvement to adapt to the business requirements. The Sr. Director - Quality - Small Molecule API...+ Ensuring staff are qualified and that the required training of all quality personnel is completed… more
- Datavant (Indianapolis, IN)
- …realize our bold vision for healthcare. Datavant is seeking a strategic and hands-on ** Director of Quality ** to lead product and supplier quality assurance ... solutions through tokenization, data linkage, and privacy-preserving analytics. As Director of Quality , you will own the...compliance . + Manage and mentor a team of quality specialists responsible for core functions such as CAPA,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- The Director , Global Product Quality , GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global ... solutions that enhance compliance and operational efficiency. + GMP Compliance : Ensure all quality processes meet global regulatory requirements (eg,… more
- Lilly (Lebanon, IN)
- …successful startup into GMP manufacturing operations._ **Main Purpose and Objectives:** The Senior Director - Quality Control is part of the Senior Leadership ... Team of the Lilly Lebanon API site (LP1). The QC Senior Director provides administrative and technical leadership in the development, performance, and maintenance of… more
- Lilly (Lebanon, IN)
- …with a cross-functional group. **Additional Skills/Preferences:** + Strong knowledge of Quality Management Systems, Site Compliance processes, and regulatory ... advanced data collection and analysis platforms that will deliver improvements in safety, quality , and process performance. This is a unique opportunity to be a part… more
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