QC/QA Manager – Pharmaceutical Manufacturing

Description

Recruit AI is seeking an experienced Quality Control Manager to lead the Quality Control department, ensuring that all raw materials, in-process productions, and finished goods consistently meet the highest regulatory and quality standards. In this leadership role, you will manage a team of 5 professionals to maintain compliance with GMP and ISO 9001 quality management systems and oversee laboratory operations. The ideal candidate has a strong background in pharmaceutical or pharma-related manufacturing quality systems and has demonstrated success in managing quality control teams and driving continuous improvement initiatives. As the Quality Control Manager, you will be responsible for developing and maintaining Standard Operating Procedures (SOPs), leading internal and third-party audits, and ensuring thorough documentation and reporting. You will collaborate closely with Production, Research and Development, and Procurement departments to resolve quality issues and monitor supplier performance. Staying current with evolving pharmaceutical regulations and industry best practices is essential to recommend and implement necessary improvements throughout the manufacturing process.

Responsibilities

• Lead and manage the Quality Control department to ensure efficient and compliant operations.
• Develop, implement, and maintain Standard Operating Procedures (SOPs) for testing raw materials, in-process samples, and finished products to meet defined quality specifications.
• Ensure continuous compliance with Good Manufacturing Practices (GMP) and ISO 9001 quality management system requirements.
• Oversee calibration, validation, and maintenance of all QC laboratory instruments and equipment to guarantee reliable testing results.
• Investigate quality deviations, out-of-specification (OOS) results, and customer complaints through thorough root cause analysis, driving corrective and preventive actions (CAPA).
• Prepare and maintain comprehensive quality documentation, batch records, and audit trails required for internal and external regulatory inspections.
• Coordinate and lead internal quality audits; support external audits conducted by regulatory bodies, customers, and certification agencies.
• Train, mentor, and develop QC staff on proper testing protocols, documentation standards, and current regulatory requirements.
• Collaborate with Production, Research and Development, and Procurement teams to resolve quality issues and support vendor qualification processes.
• Monitor supplier quality to ensure raw materials meet the company’s quality standards and support continuous improvement initiatives.
• Report regularly to senior management on quality metrics, trends, key performance indicators (KPIs), and improvement plans.
• Stay up to date with evolving pharmaceutical quality regulations and industry best practices, recommending system and process improvements as needed.

Experience

8 Years

Apply By

Oct 21, 2026

Required Skills

• Compliance Monitoring
• GMP
• Quality Control
• Root Cause Analysis
• CAPA
• Regulatory Audits
• Customer Audits
• Quality Documentation
• Team Management
• Analytical Skills
• Problem-solving
• Communication Skills
• SOP development
• Audit coordination
• ISO 9001

Nice to Have Skills

• Report-Writing
• Laboratory Operations
• Vendor Qualification
• Continuous Improvement
• Quality Metrics Reporting