Quality Auditor (Eastern Europe)

Qualifyze; Warszawa; Sur place; PLN 109 000 - 175 000; Plein temps

Avantages offerts par ce poste

Competitive compensation

Paid vacation package

Flexible schedules

Work from abroad up to 45 days

Work equipment provided

Company events

Coaching & mentoring

Supportive team environment

Résumé du poste

Qualifyze is seeking a Quality Auditor to independently manage audits across an international supplier network. You will collaborate with customers, suppliers, and internal teams to drive quality improvements and regulatory compliance in the Life Sciences sector.

The role requires 5+ years GMP auditing experience, a relevant degree, and strong English proficiency with additional European languages as a plus. Travel for audits is expected domestically and internationally.

Qualifications

• Strong organizational and communication abilities essential for audits.
• Excellent report-writing and documentation skills.
• Fluency in English and one of: Polish, Czech, German, Hungarian, Romanian, Bulgarian, Slovakian or Serbian.

Responsabilités

• Prepare GxP audits and ensure regulatory compliance.
• Conduct 40 remote and on-site audits per year.
• Assess compliance against GMP/GxP regulations and internal procedures.
• Produce clear audit reports and support cross-functional reviews.
• Review supplier CAPA responses and ensure corrective actions.

Connaissances

Organizational skills

Communication skills

Report-writing skills

English proficiency

Formation

Bachelor's or Master's degree in Pharmacy, Chemistry, Biotech, Life Sciences

Description du poste

About Qualifyze:

Founded in 2019, Qualifyze is a leading company in supply chain compliance management in the Life Sciences industry, trusted by over 1,500 pharmaceutical and healthcare companies globally. Our digital suite of solutions connects manufacturers, suppliers, and a global network of more than 250 auditors and quality experts.

With a track record of over 4,500 audits across 85+ countries and the largest and most accurate supplier network and data analytics tools, Qualifyze stands as the all-in-one partner for quality compliance and supply chain risk mitigation in the Life Sciences sector.

As a Quality Auditor, you will play a key role in ensuring pharmaceutical suppliers meet the highest standards of quality and regulatory compliance. Working within the Quality team, you will independently manage and conduct audits across an international supplier network, collaborating closely with customers, suppliers, and internal stakeholders to drive quality and continuous improvement.

Main Responsibilities:

• Prepare GxP audits, ensuring customer requirements and applicable regulations are adequately addressed.

• Conduct 40 remote and on-site audits of pharmaceutical providers per year.

• Assess compliance against applicable GxP regulations, guidelines, and internal procedures.

• Prepare clear, accurate, and timely audit reports in accordance with internal quality standards.

• Participate in the audit report review process, collaborating with cross-functional teams to ensure consistency and quality.

• Review and assess supplier CAPA responses to ensure audit findings are appropriately addressed.

• Communicate effectively with suppliers, customers, and internal stakeholders throughout the audit lifecycle.

• Maintain up-to-date knowledge of applicable GxP regulations and industry best practices.

• Support continuous improvement initiatives related to auditing methodologies, procedures, and quality processes.

Job Requirements:

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biotech, Life Sciences, or related field.

• Minimum 5 years of GMP auditing experience in the pharmaceutical industry.

• Evidence of relevant and accredited auditor training or justified experience in auditing with experienced inspectors.

• Strong knowledge of international GMP regulations and quality systems.

• Excellent organizational, communication, and report-writing skills.

• Professional proficiency in English and one of the following languages: Polish, Czech, German, Hungarian, Romanian, Bulgarian, Slovakian, or Serbian. Any additional languages would be a plus.

• Willingness to travel for on-site audits (domestic and international).

Salary:

At Qualifyze, our salary ranges are transparent internally, and we aim to follow a similar approach externally. For this role, we're happy to share a reference point within the band: the expected salary range is around €25.000 – €40.000 centred around the median.

Final compensation will depend on experience and performance during the process, with some flexibility within the range. Your exact employment terms will be in line with the local laws and regulations of your country of employment.

What do we offer?

• Competitive, annually reviewed compensation package.

• Country vacation package that increases with your tenure.

• Flexible schedules throughout the year.

• The option to work from abroad for up to 45 days per year.

• All necessary work equipment (laptop, headphones, etc.).

• Two official company events per year to celebrate success.

• Individual coaching and mentoring on your development roadmap within Qualifyze.

• Working with an exceptional team, doing some of the best work of your career.

Use of AI in Our Recruitment Process:

We believe in a human-led hiring process. All applications are reviewed manually by our Talent Acquisition team, and neither Talent Acquisition nor Hiring Managers use AI to screen, filter, rank, assess, or make decisions about candidates, including during interviews and assessments. During interviews, AI may be used only to support note-taking and transcription.

All hiring decisions are made by people!

Diversity & Inclusion at Qualifyze:

At Qualifyze we actively support the power of diversity, uniting complementary talents and perspectives to address new challenges. Our collective strengths help us to find innovative solutions and turn difficulties into opportunities.We will encourage you to bring your authentic self to work, fostering an inclusive environment where everyone belongs and feels heard.

We are an equal opportunity employer and we welcome applications from candidates of all backgrounds, regardless of race, ethnicity, gender identity, sexual orientation, marital status, religion, disability, or age. Our hiring practices are rooted in fairness and respect, and we strive to create a culture where everyone feels valued and empowered.