Sr. Specialist, Quality Engineer
Confirmed on the employer's own hiring board on Nov 2, 2026. First seen by Alion on Oct 28, 2026.
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 inquality 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.