Clinical Quality Assurance Expert/Manager (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 centres, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

As a Clinical Quality Assurance Expert/Manager at R&D Quality department, you will play a pivotal role in ensuring that our clinical research meets the highest global standards and truly improves patients’ lives. You will be the guardian of GCP compliance, a key partner to our clinical teams, and a driver of quality across all phases of clinical development. This is an opportunity to shape how we run clinical trials, influence impactful decisions, and contribute to medicines that reach patients worldwide.

Key responsibilities:

• Interpret and apply ICH-GCP guidelines, FDA/EMA regulations, and other global regulatory requirements
• Monitor industry trends and regulatory updates to ensure continuous improvement and compliance
• Identify GCP compliance risks and recommend corrective and preventive actions (CAPAs)
• Provide expert input during protocol development, site selection, and clinical trial execution
• Develop, implement, and maintain GCP compliance strategies, SOPs, and quality systems
• Conduct GCP training, ensures that training files are set-up and maintained for Clinical R&D and Clinical R&D Quality staff (Core curriculum, Ongoing training, regulations for countries)
• Participate in GCP inspection readiness programs
• Participate in internal and external audits and inspections
• Tracks GCP audits performed (ensures that audits are executed according to the annual audit plans, reported, CAPA implemented as required and audits are closed)
• Ensure Clinical Trial Master Files are available and updated for every product

What we expect:

• Master's degree in Medicine, Pharmacy, Life Sciences or related field (advanced degree preferred)
• Minimum of 7 years of experience in clinical research, with at least 3 years in a GCP compliance or QA role
• In-depth knowledge of ICH-GCP, FDA, EMA, and other international regulatory requirements
• Experience with clinical trial audits and inspections
• Strong analytical, problem-solving, and communication skills
• Ability to work independently and collaboratively in a matrixed environment
• Detail-oriented with strong organizational skills

Preferred Skills:

• Experience with regulatory agencies (FDA, Health Canada, etc.)
• Certification in GCP, Clinical Research or Quality Assurance (e.g., ACRP, SOCRA, RQA)
• Experience with electronic Trial Master File (eTMF) systems and clinical quality management tools
• Familiarity with risk-based monitoring and quality by design (QbD) principles
• Multinational clinical trial experience

What we offer:

• Collaboration across teams and functions, building relationships with colleagues from different departments and regions; opportunity for professional growth in scientific field and global network
• Permanent full-time position
• Competitive compensation package
• Annual health check-up and incident insurance policy
• Monthly food and travel allowances
• Free drinks, fruit and parking slot

If you are collaborative, like to innovate in the way you work, care about others, and are itnerested in a career where you can make a positive impact on people’s lives, apply no later than February 28th, 2026.