Quality Auditor (Eastern Europe)

qualifyzegmbh; Polska; On-site; PLN 109,000 - 175,000; Full time

Benefits offered by this job

Competitive compensation

Annual vacation package

Flexible schedules

Work from abroad up to 45 days/year

Laptop and work equipment

Company events

Coaching and mentoring

Collaborative team environment

Job summary

Qualifyze, a leader in supply chain compliance in Life Sciences, seeks a Quality Auditor. You will manage audits across an international supplier network, ensuring GMP standards and regulatory compliance are met.

You’ll collaborate with customers, suppliers, and internal teams to drive quality improvements. Role requires 5+ years in GMP auditing, strong English, and willingness to travel domestically and internationally.

Qualifications

• 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 auditor training or justified auditing experience.
• Strong knowledge of international GMP regulations and quality systems.
• Excellent organizational, communication, and report-writing skills.
• Professional proficiency in English and Polish or other listed languages.
• Willingness to travel for on-site audits.

Responsibilities

• Prepare GxP audits, addressing customer requirements and regulations.
• Conduct 40 remote and on-site audits per year.
• Assess compliance against GMP and internal procedures.
• Prepare clear, timely audit reports per quality standards.
• Participate in audit report reviews with cross-functional teams.
• Review supplier CAPA responses to address findings.
• Communicate with suppliers, customers, and stakeholders throughout the audit lifecycle.
• Maintain up-to-date knowledge of GxP regulations and best practices.
• Support continuous improvement of auditing methodologies.

Skills

GMP auditing

Regulatory knowledge

Audit reporting

English proficiency

Education

Bachelor/Master in Pharmacy or Life Sciences

Job description

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.