Senior Principal Scientist - Clinical Quality Auditor

Vacancies
Senior Principal Scientist - Clinical Quality Auditor

Job Introduction

Thanks for checking out our vacancy, we're delighted you want to learn more about Dechra!

Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.

Our values are embedded within our culture and thrive within our family of almost 3000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.

The Opportunity

To implement and maintain compliance program for Dechra Product Development Global 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).

Role Responsibility

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
• Responsible to establish and execute quality plan/audits for Dechra clinical trials.
• Provision of regulatory training for Product Development Organization
• Provide Sponsor QA oversight of GLP studies conducted by third party laboratories
• Serve as Clinical Quality Representative on Dechra Product Development Project teams
• 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
• Serve as Sponsor Quality for clinical efficacy studies

The 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:

• 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
• Animal Health focused experience Effective communication skills Ability to present information for training

Additional Information

• Expected travel 20-25% (domestic and international)

About the Company

As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an other incentives for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.