Senior Auditor (Technology & CSV)

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 Auditor (Technology & CSV) to join their innovative and collaborative team.

We are looking for a Senior Auditor to join diverse, dynamic, and dedicated Tech QA team. In this position, you will be instrumental in maintaining the quality and compliance of clinical trials, interpreting regulatory standards, and supporting the development of cutting-edge treatments and therapies.

Senior Auditor (Technology & CSV)

Location: Bulgaria, Poland (home-based)

Duties and Responsibilities:

• Utilizing a strong knowledge of regulatory expectations and industry knowledge you will provide expert consultancy and compliance advice within the company for current and emerging technology related topics, such as eClinical Systems and AI;
• Perform a variety of audit activities including internal process audits (with a technology component), technology vendor audits, computerized system and equipment audits;
• Perform Data Integrity Reviews of processes/systems and Validation Assessments of computerized systems;
• Participate as a Technology related Subject Matter Expert during inspections, sponsor audits and in support of Quality Issues;
• Mentor and train junior staff.

Qualifications, Skills & Experience:

• Bachelor's degree in Life Sciences, Pharmacy, IT or related field; advanced degree preferred;
• Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechnology, healthcare or CRO industry;
• Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues spanning multiple systems and/or business areas;
• Proven auditing experience of computerized systems, processes and vendors used in a clinical development and manufacturing setting;
• In-depth knowledge of data integrity, computerized system validation, delivery/service models, oversight frameworks and emerging trends (e.g. 21 CFR Part 11, Annex 11 & EMA Guidance, Computer Software Assurance, Agile, ITIL, GDPR, Information Security, AI);
• Familiar with regulations and guidance governing clinical trials and drug development (e.g. ICH, FDA, EMA covering GLP, GCP, GVP, GMP, GDP and Medical Devices);
• Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels;
• Ability to travel more than 20%.

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.

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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.