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Clinical Quality Specialist - Portland, ME or Overland Park, KS

Dechra Veterinary Products

Last Updated: 9/21/21

Job Description


Thanks for checking out our vacancy, We’re delighted you want to learn more about Dechra Pharmaceuticals PLC.

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.

Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 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

The Clinical Quality Specialist will proactively develop and maintain the overall quality system for Clinical and Non-clinical development programs within Product Development. The Clinical Quality Specialist will ensure that appropriate SOPs are in place to facilitate compliant conduct of GCP and GLP studies and that appropriate systems are in place to facilitate compliance with the SOPs. The Clinical Quality Specialist will implement an internal audit program to assess compliance with SOPs, regulations, and guidances as well as performing QA audits of study protocols, reports, raw data, and study sites as deemed appropriate. In addition to the QA responsibilities, the Clinical Quality Specialist may also act as a Study Monitor for any study where they are not performing any QA activities.

So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:

Quality Assurance

  • Responsible for the development and implementation of GCP/GLP quality systems which will include the following:
    • Oversight of Standard Operating Procedures (e.g. creation, updates, finalization, review)
    • Management of SOP training program
    • Audit internal records (e.g. personnel files, study files, etc) for compliance with SOPs and applicable regulations, guidelines, and Dechra policies
    • Evaluate overall process and procedures for compliance and efficiency
    • Provide Team member training as applicable
  • Responsible for the quality assurance for clinical and non-clinical studies
    • Work with CTM and Sponsor Representative to create study-specific QA plans
    • Conduct Quality Assurance (QA) audits (protocol, report, data, etc), generate audit reports, communicate results and use a collaborative approach to ensure corrective and preventative actions are taken as required
    • Qualify facilities for participation in clinical or non-clinical studies.
  • Identify regulatory compliance risks and propose proactive mitigation plans to management
  • Provide GCP and GLP compliance advice and guidance to Team members, to achieve continuous quality improvement and effective quality controls.

Monitoring (where applicable)

  • Monitor study sites and perform monitoring activities associated with site qualification, study initiation, execution, close-out, and submission
  • Serve as point of contact between Dechra and study sites

Key Performance Indicators:

  • Collaborative approach to quality assurance activities
  • Clear and effective communication
  • Attention to detail
  • Appropriate escalation of concerns

Competencies

  • Auditing
  • Collaboration and coaching
  • Relationship management
  • Compliance mindset
  • Strategic thinking
  • Problem solving

Skills

  • Demonstrate collaboration and communication skills in a team environment, share knowledge, influence best practices, and coordinate workflow.
  • Initiative to bring forward ideas for process improvements and more efficient operations.
  • Ability to communicate effectively with excellent written/verbal skills.
  • Requires exemplary relationship building skills and the ability to influence without authority.
  • Ability to conduct deep data mining.
  • Ability to exhibit sound judgement in handling confidential information.
  • Diverse problem-solving skills and strong ability to think “outside-the-box”.
  • Strong self-starter, independent, proactive, and self-motivated.

Qualifications

  • BS degree or equivalent experience required

Knowledge and Experience

  • Minimum 5 years of experience in compliance activities (GCP/GLP) related to veterinary product development
  • Demonstrated understanding of protocols, data collection methodologies, GCP guidelines, GLP regulations, and report writing.

    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 employee stock purchase plan 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.



Company Details

Overland Park, Kansas, United States
Dechra Veterinary Products, with headquarters in Manchester, England is a leader in specialized pharmaceuticals for the companion animal and equine markets. Dechra's US subsidiary located in Overland Park, Kansas is rapidly expanding to meet demands for key products under development.