What are the responsibilities and job description for the Associate Director, Quality position at Latigo Biotherapeutics, Inc.?
Latigo is seeking an experienced Associate Director, Quality to oversee the Clinical QA/QC function at Latigo.
Primary Responsibilities
Primary Responsibilities
- Collaboration with Development Team functions including Clinical Pharmacology, Clinical Development, Development Operations, CMC and Regulatory Affairs (RA)
- Business Process Owner for SOPs for the Development organization including assigning appropriate trainings to different functions
- Working with RA to prepare for Inspection Readiness
- Working with RA making sure that our submissions documents are stored correctly and compliant with FDA/EMA requirements and all documents that are submitted to the regulatory agencies have undergone proper QC
- Working with functional heads to assess external Quality vendors currently utilized and develop a strategy to streamline it
- Work with Discovery functions at Latigo to provide support including Collaborating with Preclinical Safety and ADME teams to assess their needs for establishing a Quality system.
- MSc or PhD in a Life Science area
- 8-10 years experience in Pharma
