Quality Control Manager (Pharma)

Role Overview

This role leads quality control for a pharmaceutical manufacturing operation, overseeing laboratory testing from incoming materials through finished products. By maintaining reliable analytical processes and strong compliance practices, the QC Manager helps ensure that product decisions are supported by accurate results and that manufacturing quality risks are addressed promptly.

Key Responsibilities

• Direct day-to-day laboratory work and ensure timely testing of raw and packaging materials, intermediates, and finished products.
• Set and maintain testing specifications, procedures, SOPs, and related quality records.
• Monitor compliance with cGMP, GLP, applicable regulatory requirements, and data integrity expectations.
• Oversee analytical method validation, stability studies, instrument calibration and qualification, and laboratory upkeep.
• Review batch documentation and laboratory results, making decisions on material and product acceptance or rejection based on QC evidence.
• Lead investigations into deviations, out-of-specification results, and customer complaints, and coordinate corrective actions.
• Prepare for and support internal and external audits and regulatory inspections; contribute to quality risk management and ongoing improvement.
• Manage laboratory resources, budgets, performance objectives, and the training and development of QC staff.

Requirements & Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Pharmaceutical Sciences, Microbiology, Laboratory Technology, or a related scientific discipline.
• At least seven years of QA/QC experience in pharmaceutical manufacturing, including five or more years in a managerial position.
• Substantial experience with pharmaceutical QC testing, analytical methods, laboratory operations, and quality management systems.
• Detailed knowledge of cGMP, GLP, regulatory compliance, SOPs, and pharmaceutical quality standards.
• Practical experience in method validation, stability testing, equipment qualification, audits, and quality investigations.
• Familiarity with QC laboratory instruments, analytical equipment, and electronic or paper-based quality documentation systems.
• Strong people leadership, analytical judgment, problem-solving, planning, and communication skills.
• Proficiency with Microsoft Office and laboratory reporting systems.