Senior Auditor - Clinical QA

Dechra Pharmaceuticals PLC; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading veterinary biotechnology company is seeking a Senior Auditor - Clinical QA to ensure compliance with regulatory guidelines and provide quality oversight for animal health research. The role involves coordinating inspections, conducting vendor audits, and generating quality assurance procedures. The ideal candidate will have a strong background in quality assurance and a Bachelor's degree in a related field.

Benefits

Wellness sessions

Flexible work arrangements

Generous employer 401k match

Qualifications

• Quality Assurance experience with 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 Clinical Quality Assurance Standard Operating Procedures.

Skills

Quality Assurance

Risk Assessment

Compliance

Education

Bachelor's Degree in Science

Job description

Vacancies

Senior Auditor - Clinical QA

Job Introduction

*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 to ensure 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)).

Role Responsibility

What will you be doing? This role has a broad and varied scope, and the successful candidate will have responsibilities including:

• 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 review supporting Policies and Procedures.
• Align Invetx and Dechra Clinical Quality Assurance Standard Operating Procedures and Policies.
• Establish and execute quality plans/audits for Invetx clinical trials.
• Provide regulatory training for the 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 policies, and health, safety, and environment (HSE) policies.
• Perform other duties as determined by company management.

The Ideal Candidate

We pride ourselves on being an inclusive employer and welcome candidates from all backgrounds. We are particularly interested in candidates who have or are:

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

About the Company

As a culture that values people, we offer free weekly wellness sessions focused on employee physical and mental wellbeing, flexible work arrangements, a generous employer 401k match, and other incentives for long-term financial wellness. Our comprehensive health, financial, and voluntary benefit programs reflect our recognition as a Best Place to Work.