General Manager

Job Description : General Manager (Quality Head – QA/QC) BREMEN GERMANY Open to International candidates with 20+ years experience Position: General Manager – Quality (QA/QC) We are looking for an experienced Quality Head / GM Quality (QA/QC) to lead the Quality function for a pharmaceutical manufacturing facility. The candidate will be responsible for driving Quality Assurance and Quality Control systems, regulatory compliance, audits, and continuous improvement initiatives for an OSD (Oral Solid Dosage) manufacturing plant. Key Responsibilities: Lead and manage QA & QC functions including Quality Systems, Documentation, Compliance, and Laboratory operations. Ensure compliance with EU GMP requirements and regulatory standards. Handle and prepare the site for European regulatory audits / customer audits. Drive implementation and effectiveness of Quality Management Systems (QMS). Oversee deviations, CAPA, change control, investigations, and risk assessments. Ensure regulatory compliance related to GMP, GLP, GDP, and data integrity. Review and approve SOPs, specifications, validation protocols, and quality documents. Manage stability studies, analytical activities, method validation, and product release processes. Work closely with Production, Regulatory Affairs, Engineering, and Supply Chain teams. Develop and mentor QA/QC teams and build a strong quality culture. Ensure successful execution of internal audits, external audits, and regulatory inspections. Candidate Profile: Bachelor’s / Master’s degree in Pharmacy or related discipline. Extensive experience in Pharmaceutical Quality (QA/QC) leadership roles. Strong experience in OSD manufacturing plants (Tablets/Capsules). Must have exposure to European audits / EU regulatory requirements. Strong knowledge of GMP compliance, regulatory expectations, and quality systems. Excellent leadership, communication, and decision-making skills

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