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Senior Auditor, Clinical Quality And Compliance, Poland

Innovaderm Research
Innovaderm Research
5-10 years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🌟 Now Hiring: Senior Auditor, Clinical Quality and Compliance (Poland) 🌟

💼 Position: Senior Auditor, Clinical Quality and Compliance
🏢 Industry: Corporate - Quality and Compliance
📍 Location: Poland (Remote)
Job Type: Full-time

🔎 Job Overview

The Senior Auditor, Clinical Quality and Compliance will lead audit plans, assess and secure compliance during study conduct, and provide GxP consultation to support operations. The role offers mentorship and an opportunity to contribute your experience and expertise in audits for clinical sites, studies, and vendors.

🔑 Key Responsibilities

Lead and implement robust audit plans in line with established audit programs
Mentor audit teams conducting site, study, internal, and vendor audits
Coordinate clinical site audits with the project management team, and facilitate audits with external auditors when applicable
✔ Review audit reports, form recommendations, and track the progress of action items
Provide GxP consultation and guidance on audit techniques, risk assessments, and corrective actions
Organize sponsor study audits and regulatory inspections, including mock inspection activities
✔ Develop and provide training content on SOPs, regulations, and GxP standards
✔ Collaborate closely with the Quality Systems group on internal audits, vendor audits, and risk reviews

📌 Requirements

🎓 Education:

  • Bachelor’s degree in a relevant discipline or equivalent experience

🛠 Experience:

  • 5-10 years in clinical quality in the pharmaceutical or research industry
  • Proficient knowledge of ICH guidelines, FDA, EU, and local regulatory requirements, including Health Canada regulations

📜 Skills & Competencies:

  • Mastery of audit processes and risk determination
  • Fluency in Polish and English (written and oral)
  • Ability to communicate effectively and manage audit findings
  • Strong organizational skills and adaptability to dynamic environments
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

Travel: Ability to travel 10-30% of the time

🎯 Perks & Benefits

Flexible work schedule
Home-based position
Ongoing learning & development
Vacation time
Permanent full-time position

📌 Company: Innovaderm (Specialized in Dermatology CRO Research)
📌 Legal Requirement: Applicants must be legally eligible to work in Poland

📩 Apply Now!