Quality Auditor (Spain)

Qualifyze; España; Hybride; EUR 40 000 - 50 000; Plein temps

Résumé du poste

Qualifyze, a leader in supply chain compliance in Life Sciences, seeks a GMP Auditor to validate audit requests and convert them into scheduled audits. You will conduct 40 remote and on-site audits yearly, ensuring GxP compliance and timely reporting.

The role requires a pharmacy/biotech background, 5+ years GMP auditing experience, and fluency in Spanish and English, with travel domestically and internationally. Hybrid work with global opportunities.

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 relevant auditor training or justified auditing experience with inspectors.
• Strong knowledge of international GMP regulations and quality systems.
• Excellent organizational, communication, and report-writing skills.
• Professional proficiency in Spanish and English; other languages are a plus.
• Willingness to travel for on-site audits (domestic and international).

Responsabilités

• Prepare GxP audits addressing customer requirements and regulations.
• Conduct 40 remote and on-site audits per year.
• Assess compliance against GxP regulations, guidelines, and procedures.
• Prepare clear, accurate audit reports per internal standards.
• Review audit reports with cross-functional teams for quality.
• Assess CAPA responses to ensure audit findings are addressed.
• Communicate effectively with suppliers, customers, and stakeholders.
• Maintain up-to-date knowledge of applicable GxP regulations.

Connaissances

GxP regulations knowledge

Audit planning

Communication skills

Report writing

Organizational skills

Bilingual Spanish/English

Travel readiness

Formation

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

Description du poste

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.

Job requirements

We are looking for a GMP Auditor to join our Quality team. You will validate incoming customer audit requests and convert them into scheduled audits by negotiating optimal dates with supplierspartnering closely with internal teams to ensure smooth, on-time execution.

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 both Spanish and English. French, Italian, or German would be a plus.
• Willingness to travel for on-site audits (domestic and international).

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 40k – 50k €, centred around the median.

Final compensation will depend on experience and performance during the process, with some flexibility within the range.

What do we offer?

• Competitive, annually reviewed compensation package
• Country vacation package that increases with your tenure
• Country specific benefits offering incl. private health care, fitness and meal allowances
• Annual personal development budget to increase your impact
• Hybrid working mode, plus up to 3 months of the year work from anywhere.
• All the best kit and tools to work effectively
• Annual in person all company event and celebration in Europe
• 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.