Senior Auditor, Clinical Quality and Compliance

Description

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

This role will be perfect for you if:

• You approach challenges with an understanding of norms and regulations, combined with a creative and inquisitive mind
• You enjoy working with a small team, contributing your experience and expertise to complete a variety of tasks , including special projects
• You love being a mentor in different types of audits

RESPONSABILITIES

More specifically, the role of Sr Auditor, Clinical Quality and Compliance includes:

• 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). Performs review of audit of reports issued by the auditors.
• Coordinate and conduct clinical sites audit with the project management team. Where applicable, facilitate the audit with the external auditors.
• Participate in the auditor’s training in providing guidance on audit techniques, risk assessment and system approach.
• Formulate observation/recommendations and review appropriateness of audit responses/CAPA plan and track progress.
• Review and assess non-compliances, adequacy of CAPA plan and track the progress of action items. Lead thorough and complete investigations where needed.
• Provide solid recommendation/guidance via GxP consultation and support auditor in their consultation as needed.
• Organize and hosts sponsor’s study audits and regulatory inspections including mock inspection activities.
• Work closely with the Quality Systems group for internal, vendor audits and periodic risk review of vendors. Can also be involved in client’s qualification audits and review of SOPs.
• Develop training content for topics related to SOP, regulations and GxP. Can provide training to Innovaderm employees.
• Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.

Requirements

Education

• Bachelor degree in a relevant discipline or equivalent experience;

Experience

• 5-10 years’ experience in the pharmaceutical or research industry (more 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 skill and ability to adapt to a rapidly growing environment
• Fluency in Polish and English is required.
• Proficiency in additional languages is considered a valuable asset
• Good knowledge of the Microsoft Office Suite (Word, Excel, PowerPoint)
• Willing to travel 10-30% of the time

Our company

The work environment

 

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: what to expect

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

About Indero  

A Global Clinical Leader In Dermatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectiv