Job Description

Are you passionate about ensuring the highest standards in pharmaceutical distribution? Join our team as a Senior Quality Assurance Specialist (GDP Quality Responsible Person for Hungarian market) and play a pivotal role in safeguarding product quality, enabling patient access to our products, and ensuring GDP compliance across Hungary operation.

About the Role

As the Quality Responsible Person, you will be the cornerstone of our quality assurance efforts, ensuring that the distribution of our products within Hungary meets all Good Distribution Practice (GDP) standards, regulatory, and requirements. You will oversee the local Quality Management System, maintain compliance, and drive continuous improvement in all quality-related activities.

Based in our Budapest office—with flexible options to work from home—you will collaborate closely with colleagues from Customer Service, Regulatory Affairs, and Quality Assurance teams, both locally and at our distribution center. You will report directly to the Central East Europe In-market QA Lead, who will support your onboarding and professional growth.

Key Responsibilities

Product Release & Distribution: Oversee and authorize the release of products for distribution in Hungary, working closely with our regional warehouse Quality Responsible Person.Compliance & Quality Management: Ensure all distribution activities comply with GDP, local, and EU regulations. Maintain and continuously improve the local Quality Management System, including document management, deviation tracking, CAPAs, change controls, risk assessments, and self-inspections.Internal & External Collaboration: Serve as the primary contact for Health Authority interactions and notifications related to quality tasks. Communicate effectively with internal departments, service providers, and external agencies.Audit & Inspection Management: Lead and support audits, and inspections.Training & Development: Maintain the local training system, develop and deliver GDP-relevant trainings to employees, and manage training documentation.Incident & Complaint Handling: Assess temperature excursions, manage product quality complaints, and report suspected counterfeit, diversion, or tampering cases.Continuous Improvement: Support local and regional projects related to compliance, business initiatives, and company-wide quality initiatives.Recall Coordination: Lead local coordination and execution of recalls and mock recalls.Data Integrity: Ensure Data Integrity principles are applied to all GxP-relevant activities.

What We’re Looking For?

Education: Degree in Pharmacy (Hungary)Experience: Minimum 1 year in a Quality role within the pharmaceutical sector, with hands-on experience in GDP to be qualified as Quality Responsible Person for our WDA.Regulatory Knowledge: Strong understanding of local and EU requirements for pharmaceutical distribution and storageTechnical Skills: Experience with Document Management Systems is a plus; strong data analysis and risk assessment abilitiesCommunication: Proficient in both English and Hungarian (written and spoken); able to clearly communicate scientific and logistics topicsPersonal Qualities: Strategic thinker with a hands-on approach, high work capacity, and a collaborative mindset

Why Join Us?

Impact: Play a vital role in ensuring the safety and quality of medicines distributed across Hungary.Growth: Benefit from strong onboarding support, and be part of diverse local and regional projects to expand your QA expertise.Collaboration: Be part of a supportive, cross-functional team committed to excellence.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Temporary (Fixed Term)

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Business Initiatives, cGMP Regulations, Change Management, Customs Regulations, Deviation Management, Distribution Management, Good Automated Manufacturing Practice (GAMP), Herbal Medicines, Import Export Compliance, Managing Distribution Channels, Manufacturing Compliance, Manufacturing Quality Control, Pharmaceutical Quality Assurance, Prescription Dispensing, Product Disposition, Quality Assurance (QA) Standards, Quality Auditing, Quality Management Standards, Quality Standards, Regulatory Compliance, Regulatory Compliance Consulting, Risk Management, Self Motivation {+ 2 more}

 Preferred Skills:

Job Posting End Date:

08/25/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R359995