QA QC Manager

Role & responsibilities

1. Quality Management System

• Develop, implement, and maintain the Quality Management System (QMS).
• Ensure compliance with ISO, GMP/GDP, customer, regulatory, and internal quality requirements, as applicable.
• Establish quality policies, procedures, SOPs, specifications, and quality standards.
• Conduct periodic review and improvement of the QMS.
• Lead internal, customer, and regulatory audits.

2. Quality Control

• Oversee inspection, testing, sampling, and release activities.
• Ensure raw materials, in-process materials, finished products, and packaging materials meet approved specifications.
• Review and approve test results, analytical reports, inspection reports, and Certificates of Analysis (CoA).
• Ensure proper handling of OOS/OOT results and laboratory investigations.
• Monitor calibration, qualification, and maintenance of testing equipment.

3. Quality Assurance

• Review and approve SOPs, specifications, protocols, reports, and validation documents.
• Manage deviations, CAPA, change controls, complaints, and quality incidents.
• Ensure proper root-cause analysis and timely closure of CAPA.
• Establish and monitor quality KPIs and metrics.
• Ensure data integrity and proper documentation practices.

4. Audits & Compliance

• Plan and conduct internal quality audits.
• Coordinate customer, supplier, certification, and regulatory audits.
• Prepare teams for external inspections and ensure timely responses to observations.
• Track audit findings and verify effectiveness of corrective actions.
• Ensure compliance with applicable statutory and regulatory requirements.

5. Supplier & Vendor Quality

• Qualify and periodically evaluate suppliers.
• Review supplier quality performance and audit suppliers when required.
• Manage supplier deviations, complaints, and corrective actions.
• Monitor incoming material quality and supplier-related issues.

6. Team Management

• Lead and manage the QA/QC team.
• Define responsibilities, targets, and performance objectives.
• Conduct training and competency assessments.
• Allocate manpower and resources according to operational requirements.
• Mentor QA/QC engineers, officers, analysts, and inspectors.
• Conduct performance reviews and identify development needs.

7. Cross-Functional Responsibilities

• Work closely with Production, Engineering, R&D, Regulatory, Supply Chain, Procurement, and EHS.
• Provide quality inputs for new products, processes, equipment, and projects.
• Participate in NPD, process validation, qualification, technology transfer, and continuous improvement.
• Resolve quality issues with cross-functional teams.

8. Management Responsibilities Senior Manager Level

A Senior Manager generally has broader responsibility for:

• Overall QA/QC strategy and governance.
• Quality budget and resource planning.
• Departmental objectives and annual quality plans.
• Management review and quality performance reporting.
• Risk management and quality improvement programs.
• Escalation and resolution of critical quality issues.
• Regulatory/customer relationship management.
• Building a strong quality culture across the organization.

Preferred candidate profile

• Bachelors or Master’s degree in Quality Management, Engineering, Science, Pharmacy, Chemistry, or a relevant discipline, depending on industry requirements.
• 8–15+ years of relevant experience in QA/QC, with demonstrated experience in a manufacturing, process, pharmaceutical, chemical, engineering, or other regulated environment.
• Proven experience in quality management systems, quality control, audits, CAPA, deviations, change control, root-cause analysis, and continuous improvement.
• Strong knowledge of applicable ISO standards, regulatory requirements, customer specifications, and industry quality standards.
• Experience in managing internal, customer, supplier, certification, and regulatory audits.
• Strong understanding of quality risk management, documentation, data integrity, validation/qualification, and compliance requirements, as applicable.
• Demonstrated ability to lead, develop, and motivate QA/QC teams.
• Strong analytical, problem-solving, decision-making, and communication skills.
• Ability to work effectively with Production, Engineering, R&D, Procurement, Supply Chain, Regulatory, and other cross-functional teams.
• Experience in developing and monitoring quality KPIs, dashboards, and management reports.
• Strong leadership skills with the ability to manage multiple priorities and drive timely closure of quality issues.
• Proficiency in MS Office and relevant Quality Management/Laboratory Management systems or ERP platforms.
• Candidates with relevant professional certifications such as ISO Lead Auditor, Six Sigma, Quality Management, or other industry-specific certifications will be preferred.
• Strong commitment to quality culture, compliance, customer satisfaction, continuous improvement, and operational excellence.