Auditor, Global Quality Systems
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 Auditor, Quality Audits to bring your passion to our team. We can consider hiring ideally in Sofia, Bulgaria or Kyiv, Ukraine.
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 Auditor, Quality Audits provides support for Sponsor contracted and/or vendor audits, in accordance with applicable contract requirements, to assure that the systems, processes and performance comply with applicable laws, regulations, Standard Operating Procedures (SOPs), protocols and guidelines. The Auditor manages and supports audits and guides 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.
- Participate in contracted audits (investigator sites, trial master files, database, study reports etc.) and vendor audits across global operations (including preparation of audit plans, audit checklists, audit reports and certificates)
- Provide support to auditing programs
- 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; discussing findings with auditees
- Comply with federal, state, and local security legal requirements by studying existing and new legislation, enforcing adherence to requirements, and advising management on needed actions
- 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
- Bachelor’s degree, or international equivalent from an accredited institution, in Health or Life Sciences, or equivalent experience
- BS/BA and 2-5 years specialized GXP experience in auditing (i.e. Sponsor, site, or vendor audits), or 5+ years relevant experience
- Ability to interpret controlled documentation (i.e. protocols, validation documents, manufacturing records and data)
- Experience with electronic data management systems preferred
- Demonstrated knowledge of ICH Guidelines, FDA Code of Federal Regulations and other applicable regulatory authority laws and regulations
- Detail oriented, accurate and able to solve problems
- Experienced PC user proficient with Microsoft Word and familiar with MS Excel and MS PowerPoint
- Good 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