Summary *This is a remote position open to candidates located in the US Invetx, a division of Dechra, is a veterinary biotechnology company focused on developing protein-based therapeutics for chronic conditions in companion animals, with an emphasis on monoclonal antibodies (mAbs). Our proprietary innovation platform integrates leading industry technologies to create species-specific, half-life extended mAbs that are longer-lasting, safe, effective, and more affordable than current treatments. As part of Dechra, a global leader in veterinary pharmaceuticals, Invetx supports Dechra's mission to sustainably improve global animal health and welfare. To implement and maintain compliance program for the Invetx Development organization to assure adherence to internal policies and procedures as well as external applicable regulatory guidelines and standards (e.g. FDA, EMA, USDA). This role provides quality oversight for animal health research development activities in support of local and global projects by proactively driving compliance (Good Laboratory Practices (GLP) and Good Clinical Practices (GCP)). Main Responsibilities So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including: Responsible to coordinate preparation activities for regulatory authority inspections to enable inspection readiness at clinical sites. Conduct Vendor Audits of third party laboratories, Contract Research Organizations and other Product Development (R&D) supporting vendors (e.g. bioanalytical services, clinical supply services). Provide general quality guidance and compliance consultation. Generate/Author Clinical Quality Assurance Standard Operating Procedures and Policies and provide review for supporting Policies and Procedures. Align the Invetx and Dechra Clinical Quality Assurance Standard Operating Procedures and Policies. Responsible to establish and execute quality plan/audits for Invetx clinical trials Provision of regulatory training for Development Organization. Provide Sponsor QA oversight of GLP studies conducted by third party laboratories. Serve as Clinical Quality Representative on Product Development Project teams. Serve as Sponsor Quality for clinical efficacy studies. Comply with all Dechra local and global policies including quality frameworks, Code of Conduct, anti-discrimination/harassment and health, safety, and environment (HSE) policies. Perform any other duties or serve in such other capacity as may be determined by company management. Ideal Candidate Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We're particularly excited to hear from those who have/are: Bachelors Degree in Science, Animal Science or related field (or equivalent experience) Quality Assurance experience and working knowledge of quality management systems and processes Strong understanding of risk assessments and mitigation Demonstrates extensive knowledge in providing quality oversight for veterinary clinical studies and third party vendor assessments in support of biologicals and/or pharmaceuticals submissions Expected travel 20-25% (domestic and international) Animal Health focused experience RQAP-GLP