Senior Manager of Quality Assurance (Germany)

Company Description:

IPM Biotech, a subsidiary of BioAgilytix, is a contract research organization (CRO) in Hamburg, Germany that offers fully integrated bioanalytical laboratory services to support every stage of biologics development from early discovery through pre-clinical studies and clinical phases I, II, III and IV including custom assay development and validation and sample analysis as well as drug release testing. As a GLP, GCP/GCLP and GMP bioanalytical lab facility, IPM Biotech supports product releases of biologics, biosimilars, and biobetters.

The Position:

The principal responsibilities of this unlimited position are to provide full QA support to the European operations. The position requires the employee to manage the QA system as detailed in the Quality Management System (QMS), conduct periodic reviews of QMS, and implement CAPA. The employee will report to the Lead QA. It is expected to:

• Perform protocol, data, report, and in-lab phase audits in a technical discipline to verify conformance to applicable SOPs, methods, protocols and regulatory requirements.
• Assist the Lead QA in providing strategic and managerial oversight of the Quality Assurance (QA) operations.
• Write QA SOPs and provide regulatory input for other department SOPs and company policies.
• Host sponsor audits and government agency inspections.
• Evaluate responses to all audit/inspection reports and perform follow-up with respondents, management, or others.

Position Requirements:

• Requires a college degree in science and extensive knowledge of global GxP regulations and industry standards.
• Minimum of 8+ years working in a GLP, GCP or GMP quality environment with a minimum of 2-3 years of management experience.
• Experience in organizing and directing a cross-functional team to ensure compliance with applicable regulations for all compliance activities undertaken.
• Excellent oral and written communication skills are essential.
• Business travel will be a component of the position (travel minimally 25%).

• Fluency in English is required.
• Fluency in German is desired.
• Excellent oral and written communication skills and attention to detail.

Benefits /Future Perspectives:

• International working environment
• Attractive salary
• Bonus program
• Professional training opportunities

Are you interested? We are looking forward to receive your application in English. Please submit your complete application and include your salary expectations and earliest start date.

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