Senior Auditor - Clinical Quality Assurance

Dechra; Boston (MA); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading veterinary biotechnology company seeks a Senior Auditor for Clinical Quality Assurance. This remote role involves ensuring compliance with regulatory guidelines and overseeing quality assurance for veterinary clinical studies. Ideal candidates will have a background in science and experience in quality management systems, with a focus on animal health. Join a mission-driven team dedicated to improving global animal health and welfare.

Qualifications

• Experience in Quality Assurance and knowledge of quality management systems.
• Extensive knowledge in providing quality oversight for veterinary clinical studies.

Responsibilities

• Coordinate preparation activities for regulatory authority inspections.
• Conduct vendor audits of third-party laboratories and R&D supporting vendors.
• Generate and review Clinical Quality Assurance Standard Operating Procedures.

Skills

Quality Assurance

Risk Assessments

Compliance

Education

Bachelor's Degree in Science

Animal Science

Job description

Senior Auditor - Clinical Quality Assurance

Join to apply for the Senior Auditor - Clinical Quality Assurance role at Dechra.

Direct message the job poster from Dechra.

*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 a compliance program for the Invetx Development organization, ensuring adherence to internal policies, procedures, and external regulatory guidelines (e.g., FDA, EMA, USDA). This role provides quality oversight for animal health research development activities supporting local and global projects by proactively driving compliance with Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).

Main Responsibilities

• 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 and review Clinical Quality Assurance Standard Operating Procedures and Policies, aligning them with company standards.
• Establish and execute quality plans and audits for Invetx clinical trials.
• Provide regulatory training for the Development Organization.
• Oversee GLP studies conducted by third-party laboratories as Sponsor QA.
• Serve as Clinical Quality Representative on Product Development Project teams.
• Serve as Sponsor Quality for clinical efficacy studies.
• Ensure compliance with all Dechra policies, including quality frameworks, Code of Conduct, anti-discrimination/harassment policies, and health, safety, and environment (HSE) policies.
• Perform other duties as assigned by management.

Ideal Candidate

We value diversity and welcome candidates from all backgrounds. We are particularly interested in candidates who have:

• Bachelor's Degree in Science, Animal Science, or a related field (or equivalent experience).
• Experience in Quality Assurance and knowledge of quality management systems.
• Strong understanding of risk assessments and mitigation strategies.
• Extensive knowledge in providing quality oversight for veterinary clinical studies and third-party vendor assessments, especially supporting biologicals and pharmaceuticals.
• Expected travel of 20-25% (domestic and international).
• Experience focused on Animal Health.
• RQAP-GLP certification.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Manufacturing, Other, and Quality Assurance

Industries

• Pharmaceutical Manufacturing