Job Description Job Description Job Description
A Biopharmaceutical manufacturing solutions supplier is seeking a QA/QC Director to oversee all Quality Assurance and Quality Control activities ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards. This role leads quality systems, manufacturing operations, investigations, audits, validation activities, and continuous improvement initiatives to ensure the safety, efficacy, and quality of our bioprocess manufacturing offerings.
Develop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO 9001-2015. Manage and maintain ISO 9001 annual certification. Manage deviations, CAPAs, change controls, risk assessments, and product quality complaints. Ensure compliance with cGMP, GDP, and data integrity requirements. Lead internal audits and support customer audits. Oversee training programs related to quality systems and GMP compliance. Lead, mentor, and develop QC/QA personnel. Establish departmental goals, KPIs, and performance objectives. Qualifications:
5+ years of experience in pharmaceutical, biotechnology, or related regulated industries. Minimum of 3–5 years of management experience in QA/QC, or Quality Operations. Experience with investigations, CAPA management, and root cause analysis. Familiarity with validation, qualification, and stability programs. Strong understanding of data integrity requirements and regulatory expectations. Bachelor's degree in a scientific discipline. Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific field required. Show more Skills
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Chemistryunmatched
Continuous Improvementunmatched
Corrective and Preventative Action (CAPA) Systemsunmatched
Current Good Manufacturing Practice (cGMP)unmatched
Customer Support/Serviceunmatched
Data Qualityunmatched
GMP (Good Manufacturing Practices)unmatched
ISO 9001unmatched
Internal Auditunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Operationsunmatched
Manufacturing Systemsunmatched
Mentoringunmatched
Microbiologyunmatched
Performance Metricsunmatched
Project/Program Managementunmatched
Quality Assuranceunmatched
Quality Controlunmatched
Quality Managementunmatched
Quality Metricsunmatched
Regulatory Requirementsunmatched
Risk Analysisunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Safety/Work Safetyunmatched
Set Goalsunmatched
System Operationsunmatched
Systems Maintenanceunmatched
Training Programunmatched
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