Quality Control Manager-pharmaceutical

The Quality Control Manager will be responsible for developing, implementing, and maintaining testing procedures and standard operating procedures for quality control sampling and testing. This role includes oversight of laboratory instrument calibration and validation, investigation of quality deviations with root cause analysis and corrective actions, coordinating internal and external audits, training and mentoring staff, and collaborating cross-functionally with production, research and development, and procurement teams. The manager consistently monitors supplier and raw material quality, maintains quality records and audit trails, and reports key quality metrics to senior management. Staying current on evolving pharmaceutical regulations and industry best practices is essential to continuously improve the quality management systems and ensure compliance with customer and regulatory requirements.
Responsibilities

Lead and manage the Quality Control department, supervising a team of 5 personnel and guiding their development and performance.
Develop, implement, and maintain Standard Operating Procedures (SOPs) for quality control testing of raw materials, in-process samples, and finished goods.
Ensure compliance with Good Manufacturing Practices (GMP) and ISO 9001 standards across all quality control operations.
Oversee calibration, validation, and maintenance of laboratory instruments and equipment to guarantee accurate and reliable testing.
Investigate quality deviations, out-of-specification (OOS) results, and complaints to drive comprehensive root cause analysis and execute corrective and preventive actions (CAPA).
Prepare, review, and maintain detailed quality documentation, batch records, audit trails, and reports required for internal use as well as regulatory and customer audits.
Coordinate and lead internal quality audits and participate in external audits conducted by regulatory bodies, customers, and certification bodies to ensure continuous compliance.
Train and mentor quality control staff on testing protocols, documentation standards, audit readiness, and regulatory requirements to enhance team effectiveness.
Collaborate closely with Production, Research and Development (R&D), and Procurement teams to address quality-related issues, resolve discrepancies, and support process improvements.
Monitor supplier and raw material quality, support vendor qualification and ongoing supplier quality assurance to ensure consistency and regulatory compliance.
Report on quality metrics and key performance indicators (KPIs) including trends and areas for improvement to senior management for strategic decision-making.
Stay informed of new and evolving pharmaceutical quality regulations, standards, and industry best practices to recommend and implement improvements within the quality system.
Spearhead continuous improvement initiatives aimed at increasing efficiency, effectiveness, and compliance within the quality control function.