Title:  Specialist, Quality Assurance

Specialist, Quality Assurance (m/f/d)

Location: Zagreb

Hikma Pharmaceuticals purpose is to put better health, within reach, every day for millions of patients around the world. Through our global footprint of 30+ manufacturing plants, 9 R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

As a Quality Assurance Specialist in the R&D Quality department, you will support the implementation and maintenance of Good Clinical Practice (GCP) guidelines, regulatory requirements governing clinical trials and internal policies and procedures. Working closely with cross-functional stakeholders, you will contribute to quality oversight activities and help foster a culture of quality, compliance, and continuous improvement throughout the clinical trial lifecycle.

Key responsibilities:

• Support the implementation and maintenance of GCP compliance processes and quality systems. Assists in interpreting and applying ICH-GCP guidelines, FDA/EMA regulations, and other global regulatory requirements.
• Support development, implementation, and maintenance of SOPs, and quality documentation.
• Maintain training records and support the coordination of GCP and quality related training for Clinical R&D and Clinical R&D Quality staff
• Participate in internal and external GCP audits, regulatory inspections and inspection readiness activities.
• Support the tracking, investigation, follow-up and closing of GCP audit findings, deviations, and CAPAs
• Support the execution, tracking and documentation of annual and ad hoc GCP audit plans.
• Maintain GCP audit trackers and compliance records.
• Monitor industry trends and regulatory updates and contribute to continuous quality improvement initiatives.
• Assists in maintaining Clinical Trial Master Files (TMFs) to support completeness, accuracy, and inspection readiness.

What we expect:

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine or related field.
• Minimum of 2 years of experience in clinical research
• Demonstrated knowledge of ICH-GCP, FDA, EMA, and other international regulatory requirements.
• Experience supporting clinical trial audits and inspections.
• Strong analytical, problem-solving, and communication skills.
• Ability to work collaboratively in a matrixed environment.
• Ability to manage multiple tasks and priorities with attention to detail.
• Strong organizational and documentation skills

Preferred Skills:

• Exposure to interaction with regulatory agencies (FDA, EMA, Health Canada, etc.)
• Certification in GCP, Clinical Research or Quality Assurance (e.g., ACRP, SOCRA, RQA) is a plus.
• Experience with electronic Trial Master File (eTMF) systems and clinical quality management tools.
• Familiarity with risk-based monitoring and quality by design (QbD) principles
• Experience supporting global or multinational clinical trials.

What do we offer:

• Collaboration across teams and functions, building relationships with colleagues from different departments and regions; opportunity for professional growth in scientific fields and global network.
• On-site work with the opportunity to work from home one day per week.
• Competitive compensation package.
• Annual health check-up and incident insurance policy.
• Free drinks, fruit, and parking slot.

If you are collaborative, like to innovate in the way you work, care about others, and are interested in a career where you can make a positive impact on people’s lives, as soon as possible but no later than September 27, 2026.