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.