Senior Auditor, Quality Assurance

KCR Placement is a full-service functional sourcing and recruitment provider. We specialize in high-speed and high-quality talent sourcing for the CRO, Pharmaceutical, Biotech and Medical Device industries across Europe. 
Our employees are KCR Placement's most crucial asset. We commit to placing our candidates at the center of all we do and prepare them for long-term career development and success with competitive benefits and vibrant work environment. 
The KCR Placement team is supported by a specialized referral network of expert professionals and is dedicated to providing sourcing services and client support from job requisition to job offer. 

On behalf of our partner, one of the global leaders in clinical research, we are seeking an experienced Senior Senior Auditor, Quality Assurance to join their innovative and collaborative team.

Senior Auditor, Quality Assurance will oversee complex quality issues, including supporting root cause analysis, impact assessments, and the development of effective Corrective and Preventive Action (CAPA) plans. This role will also involve addressing audit findings and contributing to audit responses to ensure compliance with corporate policies, industry standards, and applicable regulations.

Senior Auditor, Quality Assurance - Quality & Compliance QI/CAPA team

Location: Bulgaria or Poland (hybrid/ home-based)

Duties and Responsibilities:

Independently conducts the following activities as assigned by Quality & Compliance (Q&C) management:
•    Manage Quality Issues;
•    Lead Quality Issue Investigations;
•    Supports Operations in Root Cause Analysis and CAPA Plan preparation;
•    Support Effectiveness Check development and outcomes;
•    Manage CAPAs resulting from Sponsor Audits, Inspections and/ or Internal Audits;
•    Assist with the implementation and maintenance of an effective Quality Management System/Quality Assurance program within the relevant Quality & Compliance (Q&C) team;
•    Support business development activities and Q&C initiatives as needed;
•    Read, write and speak fluent English.

Qualifications, Skills & Experience:

•    6+ years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/pharmaceutical/healthcare industry;
•    Advanced knowledge of GCP (Good Clinical Practice);
•    Excellent organizational skills;
•    Knowledge of internal auditing standards;
•    Must possess a technical knowledge that is applicable to clinical drug development;
•    An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required;
•    Experience in investigator site, vendor, and process audits;
•    Open to occasional travel, if required;
•    Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel);
•    Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems, and makes recommendations in the face of complexity, conflicting pressures, and ambiguous circumstances;
•    Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages;
•    Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision.

Benefits:

• Various annual leave entitlements;
• A range of health insurance offerings to suit you and your family’s needs;
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead;
• Global Employee Assistance Program;
• Life assurance;
• Country-specific flexible benefits, including options like gym membership discounts, childcare vouchers, and more.

Our Privacy Policy

As KCR became part of the ICON group, your personal data will be shared with ICON and processed in accordance with privacy notice: https://www.iconplc.com/privacy/job-applicants

If you want your candidacy to be considered also for future recruitments, please send us an additional consent: “I agree to the processing of my personal data for any future recruitments conducted by ICON”. Such consent may be placed in your CV or electronic correspondence addressed to us. You can withdraw your consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.

KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.

We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.