Cluster Quality Lead for CZ

Job Description

Join us as Cluster Quality Lead for CZ & SK, where you'll own end-to-end quality oversight across the Czech Republic and Slovakia- leading a team of QA professionals. You'll be the primary country contact for Health Authorities and our stakeholders, front key HA interactions, and ensure compliance with cGDP and regulatory requirements. You will enhance our Quality Management System, lead audits and self-inspections, apply quality risk management, drive training and CAPAs, manage complaints and HA reporting, and oversee deviations, change control, and quality governance for outsourced warehousing, distribution. You'll safeguard patient safety while coaching your team and partnering with supply chain to ensure reliable, compliant supply. You'll influence the CZ & SK quality strategy, be part of Czech extended Leadership team, and champion continuous improvement. If you're a seasoned QA leader ready to shape the quality agenda across two markets, we'd love to hear from you.

Keyresponsibilities:

• Health Authority (HA) interactions and notifications regarding Quality and Supply issues

• Local coordination and execution of products recalls/withdrawals

• Primary country contact for GDP Quality topics within our affiliate

• Primary country contact for HA issues pertaining to Quality and Supply issues

• Act as Cluster Quality Lead CZ & SK

• Act as Qualified Person for Distribution for Czech Republic and back up person for Slovakia

Requitements:

• Fulfil regulatory requirements to be appointed as Qualified Person for Distribution on distribution license

• Fluent in English and Czech language is a must

• Knowledge of quality assurance environment at Professional level

• Very good knowledge of regulatory environment

• Very good knowledge of supply chain environment

• Very good knowledge of pharmacovigilance environment

What we offer

• Exciting work in a great team, global projects, international environment

• Opportunity to learn and grow professionally within the company globally

• Hybrid working model, flexible role pattern

• Pension and health insurance contributions

• Internal reward system plus referral program

• 5 weeks annual leave, 5 sick days, 15 days of certified sick leave paid above statutory requirements annually, 40 paid hours annually for volunteering activities, 12 weeks of parental contribution

• Cafeteria for tax free benefits according to your choice (meal vouchers, Lítačka, sport, culture, health, travel, etc.), Multisport Card

• Vodafone, Raiffeisen Bank, Foodora, and other discount programs

• Up-to-date laptop and iPhone

• Parking in the garage, showers, refreshments, library, music corner

• Competitive salary, incentive pay, and many more

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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

English Language, Pharmaceutical Industry, Pharmacovigilance, Regulatory Experience, Supply Chain

Preferred Skills:

Job Posting End Date:

09/30/2025

• 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:R366009