Assistant Manager - Global Quality GMP Auditor

Position Summary:

GMP Auditor

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:

• Bachelors 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