Quality Assurance Coordinator

Medicover Integrated Clinical Services (MICS) is a specialised business unit with the objective to help bring innovative therapies and diagnostics to the market. MICS is focusing on clinical applications and clients from pharmaceuticals, diagnostics biopharma, biotech, contract research organisations (CROs), biobanks, and other players. We have been providing bespoke services to our clients and their patients for over 20 years, making strategic use of Medicover assets, including laboratories with state-of-the-art diagnostic equipment, medical clinics and hospitals, as well as the vast expertise and enthusiasm of a workforce that has grown to more than 28,500 professionals. MICS’ services include and are organised along discrete lines of activity, including: Central Lab Services, Biospecimen Management, Patient Recruitment, Management and Data, and Precision Medicine. Tightly integrated in all Medicover geographies and beyond, MICS employs a dedicated team of highly specialized experts including clinical and diagnostics experts, contract research professionals, account managers, project managers, logistics, regulatory and commercial experts. The major markets are Germany, Ukraine, Romania and Poland.

Quality Assurance Coordinator

About the Role

We are seeking a highly motivated Quality Assurance Coordinator to support the MICS Clinical Quality Assurance (CQA) Unit in driving a company-wide quality culture. In this role, you will ensure that all SMO units operate in full compliance with ICH GCP, regulatory requirements, and internal quality standards.

Key Responsibilities

• Support the implementation of the MICS quality vision and mindset across SMO units.

• Ensure achievement of SMO quality objectives, monitoring progress and cross‑functional accountability.

• Coordinate all compliance and quality aspects for MICS SMO Business Line services.

• Maintain compliance with internal procedures, ICH GCP, FDA, EU, and country‑specific regulations.

• Guarantee adherence to client agreements and contractual quality requirements.

Operational Quality Oversight

• Perform quality assurance activities across all SMO units, including internal audits, QMS reviews, and SOP updates.

• Monitor key SMO processes through site visits, review of nonconformities, and implementation of corrective actions.

• Participate in SMO Quality Management System reviews and continuous improvement initiatives.

• Oversee qualification, compliance, and performance of affiliate and outsourced vendors.

Clinical Trial Quality

• Ensure all clinical trial–related processes are conducted according to ICH GCP and applicable regulations.

• Review patient medical records, source documents and clinical databases.

• Support SMO units in improving patient‑related outcomes and process quality.

• Ensure medical facilities meet all applicable laws and regulatory standards.

Audit & Inspection Readiness

• Coordinate vendor assessments and audits; support regulatory inspections and client audits.

• Serve as a key participant during third‑party audits and readiness activities.

• Oversee resolution of deviations, investigations, OOS, CAPAs, complaints, recalls, and risk assessments.

Training & Documentation

• Ensure quality philosophy, SOPs, and procedures are communicated and acknowledged by SMO personnel.

• Support the creation, revision, and approval of quality system documentation.

• Ensure the internal training program is executed and maintain training records.

Requirements

Education & Experience

• Master’s degree preferably in Science or Engineering.

• 3-5 years of relevant experience, including, but not limited to clinical research.

• At least 1 year in Quality Assurance and/or education in Quality Management.

Skills & Competencies

• Fluent English; other languages are an asset.

• Ability to interpret scientific literature, and regulatory guidelines.

• Strong writing and analytical skills.

• Ability to work with abstract ideas, and complex variables.

Technical Skills

• Proficiency in Microsoft Word, Excel, PowerPoint, and MS Project.

What We Offer

• Opportunity to influence quality culture and excellence across international SMO operations.

• Dynamic, collaborative work environment.

• Professional development opportunities.

• Meaningful work supporting patient safety and clinical research integrity.

• Stable employment in a company with an established market position.

• Annual discretionary bonus.

• Access to a benefits platform.

• Benefits package including private medical care for you and your loved ones, a co-financed sports card, and group insurance.

• Subsidized vacation 'Wczasy pod Gruszą'