Quality Manager – 3rd Party Manufacturing

Department: Quality Assurance / Quality Control The Quality Manager will be responsible for ensuring compliance, quality control, and regulatory adherence at third-party manufacturing facilities. This role involves auditing and monitoring third-party manufacturers, ensuring GMP compliance, product quality, and regulatory standards are met while working closely with production, regulatory, and supply chain teams.

The ideal candidate should have a strong production background with expertise in quality assurance and control.

Key Responsibilities

1. Quality Oversight of 3rd Party Manufacturers Monitor quality standards at third-party manufacturing facilities. Conduct regular site visits, audits, and inspections to ensure compliance with cGMP, WHO-GMP, USFDA, MHRA, and other regulatory guidelines. Review and approve batch manufacturing records (BMRs) and batch packaging records (BPRs).
2. Compliance & Regulatory Audits Ensure third-party manufacturers adhere to quality agreements, SOPs, and regulatory requirements. Coordinate with regulatory teams for dossier submissions, product registrations, and regulatory inspections. Manage deviations, OOS (Out of Specification), OOT (Out of Trend), and CAPA (Corrective and Preventive Actions) at third-party sites.
3. Quality Control & Product Testing Ensure raw material, in-process, and finished product testing is conducted as per standard specifications. Review stability studies, analytical data, and lab investigation reports. Collaborate with analytical labs and QC teams to ensure product quality compliance.
4. Vendor Qualification & Process Validation Conduct vendor qualification, supplier audits, and performance evaluations. Review and approve process validation, cleaning validation, and analytical method validation reports. Work with third-party manufacturers to optimize processes and improve product quality.
5. Documentation & Reporting Maintain quality agreements, technical agreements, and audit reports for third-party sites. Ensure all documentation aligns with GMP, ICH, and other regulatory guidelines. Prepare monthly quality reports, non-compliance reports, and corrective action plans.
6. Cross-Functional Collaboration Coordinate with production, supply chain, regulatory, and R&D teams to ensure smooth manufacturing operations. Provide training to third-party manufacturers on quality standards, GMP compliance, and best practices.

Requirements

Education

B.Pharm / M.Pharm Experience: 8-12 years in pharmaceutical production & quality management, with at least 3-5 years in third-party quality oversight. Technical Skills: Strong knowledge of GMP, ICH guidelines, USFDA, MHRA, and WHO-GMP compliance. Experience in quality audits, regulatory inspections, and vendor qualification.

Proficiency in process validation, analytical testing, and stability studies. Hands-on experience with ERP systems (SAP, TrackWise, or similar) and Excel for reporting.