Job Responsibilities:

• Lead and manage all aspects of the Quality Assurance function, including batch record review, change control, deviation management, CAPAs, and product release.
• Develop, implement, and continuously improve the Quality Management System (QMS) in accordance with cGMP standards and industry best practices.
• Ensure compliance with regulatory requirements (FDA, EMA, MHRA, etc.) and participate in inspections and audits.
• Oversee the review and approval of validation protocols/reports, SOPs, and other GMP documentation.
• Manage the internal audit program and coordinate supplier/vendor quality audits.
• Provide leadership and training to QA staff, fostering a culture of quality and continuous improvement.
• Collaborate with cross-functional teams including manufacturing, QC, R&D, and regulatory affairs to support new product launches and ongoing operations.
• Monitor key quality metrics and prepare regular reports for senior management.
• Investigate quality-related issues and ensure timely resolution and implementation of effective corrective actions.

Qualifications:

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biology, or a related scientific field.
• Minimum of 4-6 years of experience in Quality Assurance within the pharmaceutical industry, including 3+ years in a management or leadership role.
• In-depth knowledge of cGMP regulations and international quality standards (ISO, ICH, FDA 21 CFR Parts 210/211, EU GMP, etc.).
• Experience with regulatory inspections (e.g., FDA, EMA) and audit readiness.
• Strong leadership, decision-making, and team-building skills.
• Excellent communication, organizational, and problem-solving abilities.