Quality Manager – Pharmaceutical Industry, USA (J26-332)

Industry: Pharmaceutical Manufacturing / Biotechnology / Life Sciences

Location: USA

Position Overview

The Quality Manager is responsible for leading the Quality Management System (QMS) and ensuring compliance with FDA regulations, cGMP requirements, and corporate quality standards. The role oversees Quality Assurance, Quality Control, audits, compliance, and continuous improvement initiatives to ensure product quality and regulatory readiness.

Key Responsibilities

• Manage and maintain the Quality Management System (QMS).
• Ensure compliance with FDA, cGMP, ICH, and applicable regulatory requirements.
• Oversee QA and QC activities across manufacturing operations.
• Lead investigations, CAPA, deviations, change controls, and risk assessments.
• Coordinate internal audits, supplier audits, and regulatory inspections.
• Review and approve SOPs, batch records, validation documents, and quality reports.
• Monitor product quality metrics and implement continuous improvement initiatives.
• Support manufacturing, engineering, validation, and regulatory affairs teams.
• Lead and develop quality personnel and promote a strong quality culture.

Requirements

• Bachelor’s degree in pharmacy, Chemistry, Biology, Biotechnology, Engineering, or a related field.
• 8–15 years of experience in pharmaceutical quality management.
• Strong knowledge of FDA regulations, cGMP, ICH guidelines, and quality systems.
• Experience in pharmaceutical, biotech, sterile, API, or regulated manufacturing environments.
• Experience managing audits and regulatory inspections.

Key Skills

• Quality Management Systems (QMS)
• Quality Assurance (QA) & Quality Control (QC)
• FDA & cGMP Compliance
• CAPA Management
• Deviation & Change Control
• Root Cause Analysis
• Validation & Qualification Support
• Internal & External Audits
• Supplier Quality Management
• Risk Assessment
• SOP Development & Document Control
• Continuous Improvement
• Team Leadership & Stakeholder Management

Preferred Certifications

• ASQ Certified Quality Manager (CQM)
• ASQ Certified Quality Auditor (CQA)
• Lean Six Sigma Green Belt / Black Belt
• Certified Pharmaceutical GMP Professional (CPGP)