Quality Assurance Manager, Poland (Contractor)

Role summary

Quality Assurance Manager, Poland (Contractor) is a contract role at Medison Pharma in Belgrade, Central Serbia, Serbia (on-site). Posted 2026-10-13. Experience level: 2-5.

Job title

Quality Assurance Manager, Poland (Contractor)

Company

Medison Pharma

Location

Belgrade, Central Serbia, Serbia

Work arrangement

on-site

Employment type

contract

Category

QA & Testing

Experience level

2-5

Date posted

2026-10-13

Job description

Medison is a global pharma company providing access to highly innovative therapies to patients in international markets. Medison commercializes highly innovative therapies across international markets, helping to save and improve the lives of patients suffering from the most challenging diseases.

Medison has a deep expertise in local regulatory and market access know-how with uncompromising compliance excellence. It offers an affiliate-like partnership and tailored solutions for country-specific and regional commercialization, enabling emerging biotech companies to navigate local complexities and to expand their reach to patients in international markets.

The Quality Assurance Manager is an experienced professional and a member of the EPM QA team, supports several territories and reports directly to the Quality Assurance Associate Director, EPM. The QA Manager plays a vital role in maintaining the quality system across the countries within scope and actively contributes to EPM Quality Team initiatives and activities.

Responsibilities

Participate in designing, implementing, maintaining, and improving the quality system.

Independently initiate and review SOP updates and create new SOPs.

Oversee review of SOPs and associated documentation to ensure periodic review requirements are met

Provide hands-on quality expertise to colleagues and partners to support their quality and business needs

Participate in GxP vendor management program, vendor oversight, QTA generation and auditing including lead auditor role to evaluate partner/vendor’s Quality Management Systems, resources, premises, and equipment

Work with QA Associate Director to ensure Medison is compliant with the latest regulatory and pharmaceutical regulations and trends related to GMP and GDP

Ensure/participate in self-inspections of GMP/GDP operations are performed to schedule and identified CAPA’s are closed to plan

Participate in Medison Management Review to assess the effectiveness of the QMS and to implement continuous improvements as appropriate

Ensure change control requests, deviations, complaints and CAPA’s are recorded, reviewed and competed using risk-based principles to comply with applicable requirements

Participate in regulatory inspections and supplier audits as required

Participate in recall and mock recall operations

Carry out any other duties that may be reasonably required and assigned to you by your manager

This role covers the South Cluster (among others: Serbia, Croatia, Slovenia, Bosnia, Montenegro) and Hungary but can be extended to other territories

Requirements

Degree in science or equivalent (pharmacist is the preferred option)

At least 3 years’ experience in an active QA role in health care sector

Strong knowledge of regulatory, GDP and GMP requirements

Excellent written and verbal communication skills

Experience as quality auditor

Experience in regulatory inspections is desirable

Quality function representative on various projects

Root cause analysis and investigation skills

SOPs and other quality documents creation

Strength in critical thinking, problem solving, and decision making

Collaborative nature, self-directed and independent

Very strong organizational abilities

Fluent English