Title:  Sr. Specialist, Quality Engineer

Senior Specialist, Quality Engineer (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 Senior Specialist, Quality Engineer in the R&D Quality department, you will support the implementation and maintenance of Quality Management system for Combination Products in R&D to ensure full compliance with 21 CFR part 4, 210, 211, ISO 13485, ISO 14971, and IEC 62366. Working closely with cross-functional stakeholders, you will contribute to quality oversight activities and help foster a culture of quality, compliance, and continuous improvement through project development lifecycle.

Key responsibilities:

• Responsibility for R&D Quality activities during the development and pre-approval phase of the products and their lifecycle
• Develop and maintain Quality Management System for Combination Products in R&D
• Training responsible person (preparation of training plan and status, matrix and LMS Curricula)
• Monitor compliance, quality assurance and regulatory requirements and evaluate their impact on defined processes in R&D
• Identify continuous improvement initiatives in quality and compliance related processes in R&D
• Provide scientific and structural support to the R&D team on:

Review/approve of different product related documentation (external and internal)

Review/approve of design control documentation (21 CFR 820.30)

Review/approve of different risk assessments (including ISO 14971, FMEA, fault tree analysis)

Support activities of technology transfer (R&D to manufacturing)

Provide Change control/deviation/OOS/CAPA support during exhibit batch production and submission phase

Supporting deficiency letters responses received by Authorities

• Assure high quality of QA documentation
• Participate in all kinds of audits (internal, corporate and external audits)
• Participate in due diligences of potential external collaborators
• Supplier assessment/vendor evaluation in development phase
• Participation in GMP equipment qualifications
• Mentoring of new employees in R&D Quality
• Stays updated with regulatory and quality standards, evolutions in GXP compliance and best practices where needed, for supporting audit preparation at site.

What we expect:

• Bachelor’s degree in Life Sciences, engineering or equivalent
• Minimum of 5 years of experience in Combination products or Medical Devices area in the pharmaceutical industry
• Experience with GDocP systems (e.g., Veeva, electronic notebooks)
• Strong verbal and written communication skills (Intermediate Level in English is a must)
• Demonstrated expert knowledge of 21 CFR, ICH, cGMPs, USP, current FDA regulations, Ph. Eur., current EMEA regulations
• Strong collaboration, communication, problem-solving and decision-making skills
• Proactive mindset with a focus on continuous improvement and delivering results

What do we offer:

• Collaboration across teams and functions, building relationships with colleagues from different departments and regions
• Individual contributor role with high autonomy, visibility and influence
• On-site work with the opportunity to work from home one day per week
• Competitive compensation and benefit package

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, apply no later than October 18th, 2026.