Senior Auditor, Clinical Quality and Compliance, Poland


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 Innovaderm, 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. 

 

In this position, you will be eligible for the following perks: 

  • Permanent full-time position
  • Flexible schedule
  • Vacation
  • Home-based position
  • Ongoing learning and development

 

Work location 

The successful candidate for this position is given to work remotely anywhere in Poland.

Employees located outside of North America are expected to have some flexibility in their working hours to accommodate team or client meetings as needed. All efforts will be made by Innovaderm to accommodate various time zones of team members. 

 

About Innovaderm 

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. 

 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Innovaderm only accepts applicants who can legally work in Poland.

All Available Positions


Position Department Location
Compensation Specialist (Poland) Corporate - Human Resources Poland
Compensation Specialist (Argentina) Corporate - Human Resources Argentina
Senior Clinical Research Associate, Dermatology & Rheumatology, Germany CRO - Clinical Operations Germany
Clinical Research Associate II, Dermatology & Rheumatology, Germany CRO - Clinical Operations Germany
Project Director (Spain) CRO - Project Management Spain
Project Coordinator (Argentina) CRO - Project Management Argentina
Clinical Study Builder CRO - Biometrics Canada
Clinical Study Builder (Spain) CRO - Biometrics Spain
Clinical Study Builder (Poland) CRO - Biometrics Poland
Clinical Study Builder (Germany) CRO - Biometrics Germany
Clinical Study Builder (Argentina) CRO - Biometrics Argentina
Strategist, Patient Recruitment & Site Engagement CRO - Project Management United States
Senior Central Risk Manager (India) CRO - Biometrics India
Business Intelligence Analyst (Argentina) CRO - Technology and AI Argentina
Senior Auditor, Clinical Quality and Compliance, Poland Corporate - Quality and Compliance Poland
Corporate Finance Analyst ( Poland) Corporate - Accounting and Finance Poland
Junior Developer (Madagascar) Corporate - Accounting and Finance Madagascar
Strategist, Operational Strategy, Canada or Poland Corporate - Business Development and Marketing Canada, Poland
Senior Project Manager (Argentina) CRO - Project Managemen Argentina
Senior Project Manager CRO - Project Management Canada
Medical Monitor, Dermatology, Poland or Spain CRO - Medical Affairs Poland or Spain
Medical Monitor CRO - Medical Affairs Canada
Site Budget & Contract Specialist (India) CRO - Project Management India
Strategist, Patient Recruitment and Site Engagement CRO - Project Delivery Canada
Compensation Specialist Corporate - Human Resources Québec (province)
Manager, Statistical Programming CRO - Biometrics Canada
Senior Talent Acquisition Advisor Corporate - Human Resources Canada ( Québec)
IT Technician Level 1 Corporate - Information Technology Montréal, Canada
Site Budget and Contract Lead (Argentina) CRO - Project Management Argentina
Clinical Trial Manager II, Dermatology & Rheumatology, Poland CRO - Clinical Operations Poland
Regulatory Affairs Specialist (Spain) CRO - Scientific and Regulatory Affairs Spain
Site Budget and Contract Lead (India) CRO - Project Management India
Senior Developer (Madagascar) Corporate - Accounting and Finance Madagascar
Senior Statistical Programmer (Argentina) CRO - Biometrics Argentina
Senior Statistical Programmer (India) CRO - Biometrics India
Site Budget & Contract Specialist CRO - Project Management Canada
Specialist, Regulatory Affairs (Poland) CRO - Regulatory Affair Poland
Site Budget and Contract Lead (Spain) CRO - Start-Up Spain
Site Budget and Contract Lead (Poland) CRO - Start-Up Poland
Site Budget and Contract Lead (Germany) CRO - Start-Up Germany
Project Director- Argentina CRO - Project Delivery Argentina
Project Coordinator (Germany) CRO - Project Management Germany
Clinical Research Associate II (NV, OR, AZ) CRO - Clinical Operations United States
Central Monitor (India) CRO - Clinical Operations India
Proposal Writer Specialist Corporate - Business Development and Marketing Montréal, Canada
Clinical Research Assistant (15 hours/week) Clinical support Montréal, Canada
Associate Director, Project Delivery CRO - Project Management Canada
Clinical Trial Manager II (CTM II) CRO - Clinical Operations Canada
Clinical Study Builder (India) CRO- Biometrics India
Project Manager (Spain) CRO - Project Management Spain
Project Manager (Poland) CRO - Project Management Poland
Project Director (Germany) CRO - Project Management Germany
Project Director (Spain) CRO - Project Management Spain
Project Director (Poland) CRO - Project Management Poland
Senior Auditor, Clinical Quality and Compliance Corporate - Quality and Compliance Canada
Future opportunities General North America, Europe and India