"Caring for People's Health as a Trusted Partner" - This purpose motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options. 

Around 11,700 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA. 

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:   

Position Summary

We are seeking an experienced and highly motivated GMP Auditor to join our Global Quality team. This role is primarily responsible for conducting GMP audits of Specialty and Biosimilar products, as well as third-party suppliers across all the global regions. The ideal candidate will have deep regulatory knowledge, strong risk assessment capabilities, and experience with inspection readiness and cross-functional collaboration.

Key Responsibilities

Audit Execution & Compliance

• Planning, Preparing, Conducting and Reporting of GMP/GDP and Quality system audits at Third party contractors for Specialty/ Biosimilar products (Finished dosage manufacturers, API manufacturers, key intermediate manufacturers, Excipients Manufacturers, Packaging Material Manufacturers, Contract Manufacturers, Contract testing labs, Contract Research Organizations) to monitor that all aspects of the operational business comply with applicable GMP / GDP legal and regulatory requirements (e.g. National and EU requirements),  and the STADA Group Quality Standard in close cooperation with the Global Quality Supplier Management & Auditing Team located at STADA Arzneimittel AG Headquarter in Germany and STADA Hemofarm SRL in Romania.
• Ensure compliance with EU GMP, ICH Q7, 21 CFR 210/211, and internal STADA Group standards.
• Prepare and distribute audit reports, review CAPAs, and ensure timely closure and KPI tracking.
• Conduct due diligence and qualification audits for Biosimilars/ Specialty and new CMOs.
• Perform Pharmacovigilance and GCP audits as required.

Risk Management & Inspection Readiness

• Ensure global standards and processes developed and in place to support specialties/biologics
• Support global risk management initiatives and inspection readiness for FDA, EU, and ROW markets.
• Assess site issues, deviations, and contribute to resolution planning.
• Develop and maintain CMO risk ratings for the Global Specialties portfolio.
• Communicate high-risk CMOs and mitigation strategies to leadership.
• Inspection readiness: Participate in internal audits, CAPA evaluations, and support health authority inspections.

Collaboration & Reporting

• Align and collaborate with other regional and global auditing teams.
• Support global quality improvement initiatives and cross-functional projects.
• Prepare monthly reports, risk assessments, and maintain KPI metrics.
• Contribute to the development of global standards and auditing best practices.

Travel Requirements

• Willingness to travel across all regions

Qualifications and Experience

Education:

• Bachelor’s degree in Pharmacy, Chemistry, Biotechnology, or a related field
• MBA from a recognized institution is a plus

Professional Experience:

• 8–10 years of experience in pharmaceutical, biopharmaceutical, or chemical industry
• Hands-on experience in QA/QC, Production, or R&D functions of Specialty and Biosimilar products
• Proven track record in auditing third-party manufacturers in line with EU GMP and FDA regulations
• Strong knowledge of global regulatory requirements (EU, FDA, ICH, ROW)

Skills:

• Excellent audit and risk assessment capabilities
• Strong interpersonal and cross-cultural communication skills
• High proficiency in Microsoft Office and auditing tools
• Fluency in English (spoken and written)
• Strong organizational and multitasking abilities
• Flexible and adaptable to changing priorities and deadlines

Why is STADA

As STADA we fundamentally care for people’s health as a trusted partner. In pursuit of this purpose, we are committed to further accelerating the successful trajectory of our company.

STADA is a leading manufacturer of high-quality pharmaceuticals. With a long-standing heritage rooted in pharmacies, we are perceived as a reliable and trustworthy partner for more than 120 years. With our products we help people protect and regain a dignified and able life. With our proven Generics, we ensure that everyday health remains affordable. To our employees, we offer an attractive working environment in which they can develop personally.

Worldwide, STADA is represented in more than 30 countries in about 50 subsidiaries. Branded products such as Grippostad, Aqualor, Snup and Ladival are among the top sellers in their respective product categories.