Senior Auditor, Inspection - Remote

Quality Assurance United States


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Senior Auditor, Inspection to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

 At Premier Research, we are science-minded and heart-centered. Join us.


The Senior Auditor, Inspection is responsible for ensuring inspection readiness and compliance of the Premier Research global organization, supporting the Global Quality Systems (GQS) department in encouraging cross-functional collaboration and engagement with Sponsors, Sites and within the Premier organization prior to (and upon) being notified of a proposed Regulatory Authority inspection. This role manages and supports audits and mentors members of the team as required. These activities drive assurance that the systems, processes and performance of Premier Research comply with applicable laws, regulations, SOPs, protocols and guidelines, and meet regulatory requirements.

ROLE RESPONSIBILITIES:

· Promote the Quality Ethos at Premier

· Point of Contact for Premier Research employees for input and guidance to ensure Sponsor, Site and Premier Research is appropriately prepared/competent to handle Regulatory Inspections.

· Continually improve the Inspection readiness Framework through active involvement with projects and incorporation of best practices and lessons learned.

· Drive the mitigation of complex business and/or regulatory gaps identified during the process of managing organization-wide inspection readiness activities.

· Collaborate with the Director, Global Quality systems and Director, Project Quality Systems to coordinate training sessions for Inspection readiness training and other GQS owned training activities

· Identify solutions where process gaps and/or areas for improvement are necessary to assure compliance with GXPs, the study protocol and applicable regulations, as needed

· Ensure compliance with established internal control procedures by examining records, reports, operating practices, and documentation

· Complete audit reports by documenting audit findings

· Communicate audit findings by preparing a final report; discuss findings with auditees

· Comply with federal, state, and local security legal requirements by studying existing and new security legislation, enforcing adherence to requirements, and advising management on needed actions

· Prepare special audit and control reports by collecting, analyzing, and summarizing operating information and trends

· Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks and participating in professional societies

· Contribute to team effort by accomplishing related results as needed 

· Ability to travel up to forty percent (40%) of time

REQUIREMENTS:

· Bachelor’s degree, or international equivalent from an accredited institution, in Health or Life Sciences, or equivalent experience

· BS/BA and 5-8 years specialized GxP experience in auditing (i.e. Sponsor, site, or vendor audits), or 8+ years relevant experience

· 2 years’ experience hosting Regulatory Inspections strongly preferred

· Ability to independently manage projects and conduct gap analyses

· Intermediate SharePoint (or equivalent document system) and Microsoft Office skills

· Demonstrated knowledge of ICH Guidelines, FDA Code of Federal Regulations and other applicable regulatory authority laws and regulations

· Experienced PC user proficient with Microsoft Word and familiar with MS Excel and MS PowerPoint

· Excellent oral and written communication of the English Language

· Excellent organizational, interpersonal and communication skills 

· Excellent team player, collaborative, and effective within the quality team; able to  build strong relationships across the organization