Quality Manager/QP

SUMMARY

The QA Manager is responsible for ensuring the development and implementation of procedural quality assurance measures for manufacturing activities and customer supply, in line with the quality and regulatory policies and objectives established by Company Management.

The role is responsible for the implementation, management and oversight of the processes forming part of the Quality Management System (QMS), including the related KPIs, and for ensuring that the QMS is correctly applied.

The QA Manager will manage QA activities at the manufacturing site, collaborate with the CMC function in preparing Module 3 of product registration dossiers, and act as Quality Representative.

The role also includes responsibility for performing the duties of Qualified Person (QP) in compliance with applicable legislation, including Italian Legislative Decree 219/2006, as amended, and the relevant EU Guidelines for Good Manufacturing Practice, including Annex 13 and Annex 16.

Experience: Minimum 10 years' relevant experience within the pharmaceutical or biopharmaceutical industry , including significant experience in Quality Assurance within a GMP-regulated manufacturing or CDMO environment and substantial experience performing Qualified Person (QP) responsibilities.

Previous experience managing QA activities and personnel is required.

RESPONSIBILITIES

• Coordinate and manage QA activities, including Quality Control, validation, management of Corrective and Preventive Actions (CAPA), non-conformities, Risk Management Activities (RMA), change control, qualification and auditing of critical suppliers, product quality complaints, Product Quality Reviews (PQRs), and Batch Record Reviews for both portfolio products and products manufactured by third parties.
• Design, implement, monitor and continuously improve the QMS in accordance with applicable regulations.
• Assess the quality status achieved and report findings to Company Management.
• Support Legal Counsel in drafting contracts relating to areas within the role's remit.
• Conduct internal and external audits of company divisions and external partners, including suppliers and distributors, to verify that all activities comply with QMS documentation and applicable GMP, GDP and GVP standards.
• Collaborate in the preparation for and conduct of inspections by Regulatory Authorities.
• Define, manage and update the documentation required to describe the QMS.
• Prepare the Site Master File (SMF).
• Prepare documents describing the manufacturing process and the Investigational Medicinal Product (IMP), as required for the relevant modules of regulatory submission dossiers.
• Review the descriptive documents required for the modules comprising regulatory submission dossiers for manufactured medicinal products and the related variations.
• Draft, review and approve SOPs, Technical Reports, Quality Agreements, Specifications and Product Specification Files (PSF) in accordance with company procedures and computerised systems.
• Deliver GMP training.
• Collaborate with the Qualified Person for Pharmacovigilance (QPPV) to ensure that Pharmacovigilance activities are conducted in accordance with GVP quality standards.
• Perform Batch Record Review for Investigational Medicinal Products manufactured at the site.
• Remain up to date with developments in relevant regulations, disseminate them throughout the company and provide appropriate clarification to relevant personnel where necessary.
• Contribute to specific projects in accordance with company plans.
• Act as Quality Representative for matters relating to Medical Devices and Combination Products.
• Perform the role of Qualified Person on an ongoing basis, carrying out the duties described in Article 52(8) of Italian Legislative Decree 219/2006.
• Ensure that each batch is manufactured and tested in compliance with Italian legal requirements, the conditions of the applicable medicinal product/Investigational Medicinal Product authorisation (MA/IND/IMPD), and GMP.
• Ensure that each batch of medicinal product is manufactured and tested in compliance with legal requirements and the conditions of the relevant Marketing Authorisation.
• For medicinal products originating in countries outside the European Economic Area, verify that each imported production batch undergoes a full qualitative analysis, a quantitative analysis of at least all active substances, and any other tests and checks required to ensure medicinal product quality in accordance with the conditions of the Marketing Authorisation (AIC), without prejudice to any applicable mutual recognition agreements.
• For medicinal products