Senior Auditor, Clinical Quality and Compliance, Poland
About The Position
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 effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Poland.
