Senior Auditor, Clinical Quality and Compliance

Join to apply for the Senior Auditor, Clinical Quality and Compliance role at Indero (formerly Innovaderm)

The role of the Sr. Auditor, Clinical Quality and Compliance is to act as lead person in establishing audit plans, assessing/securing compliance in study conduct and to provide strong support to operations via GxP consultation.

Responsibilities

• Implement robust audits plan and execute audits in accordance with the established audit program.
• Act as a lead/mentor for the conduct of audit activities (site, studies, internal and vendors). Perform review of audit reports issued by the auditors.
• Coordinate and conduct clinical site audits with the project management team. Where applicable, facilitate the audit with external auditors.
• Participate in auditor training, providing guidance on audit techniques, risk assessment and system approach.
• Formulate observations/recommendations and review the appropriateness of audit responses/CAPA plans and track progress.
• Review and assess non-compliances, adequacy of CAPA plan and track action items. Lead thorough investigations where needed.
• Provide solid recommendations/guidance via GxP consultation and support auditors in their consultation as needed.
• Organize and host sponsor’s study audits and regulatory inspections including mock inspections.
• Work closely with the Quality Systems group for internal and vendor audits and periodic risk reviews of vendors. May be involved in client qualification audits and SOP review.
• Develop training content related to SOPs, regulations and GxP; may provide training to Innovaderm employees.
• Employee may be assigned other responsibilities aligned with experience and training as needed.

Qualifications

Education

• Bachelor degree in a relevant discipline or equivalent experience

Experience

• 5-10 years’ experience in the pharmaceutical or research industry, specifically in clinical quality

Knowledge And Skills

• Excellent knowledge of ICH guidelines, FDA and local regulatory requirements and EU standards and regulations, Health Canada regulations
• Master the overall audit process and risk determination
• Ability to communicate effectively both orally and in writing
• Good organization skills and the ability to adapt to a rapidly growing environment
• Fluency in Polish and English is required; proficiency in additional languages is a plus
• Good knowledge of Microsoft Office (Word, Excel, PowerPoint)
• Willing to travel 10-30% of the time

About Indero

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

Recruitment process

• As part of the recruitment process for this position you will meet various team members at Indero
• The first interview will be conducted via Teams (30 minutes) and the second via video conference (1 hour)

Note: Indero is committed to providing equitable treatment and equal opportunity to all individuals. Accommodations are provided during the recruitment process upon request. Indero requires that applicants can legally work in Poland.