Quality Manager/QP

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 intended to be placed on the market in the European Union, ensure that the packaging bears the identification labels referred to in Article 73(1)(p-bis) of Italian Legislative Decree 219/2006.
• Certify the activities referred to in the applicable documentation.
• Retain the required documentation and make it available upon request by the Health Authority.
• Immediately notify AIFA and the person responsible for the company of any material irregularity identified in a medicinal product that has already been placed on the market.
• Actively support inspections conducted by the competent Regulatory Authorities.
• Oversee the general hygiene conditions of the premises for which the QP is responsible.
• Coordinate and collaborate with the Deputy QP to ensure continuity of QP activities during temporary absences.
• Remain current with regulatory developments affecting the QP role.

REQUIREMENTS

• University degree meeting the requirements of Article 52(3) of Italian Legislative Decree 219/2006.
• Recognition by AIFA of eligibility to perform the Qualified Person role.
• Minimum 10 years' relevant experience within the pharmaceutical or biopharmaceutical industry .
• Significant experience in Quality Assurance within a GMP-regulated manufacturing or CDMO environment .
• Significant experience performing Qualified Person (QP) responsibilities within an EU pharmaceutical environment.
• Previous experience managing and coordinating QA activities and QA personnel within a pharmaceutical manufacturing environment.
• Strong experience in the management and oversight of a Quality Management System.
• Experience with Quality Assurance activities including CAPA, non-conformities, change control, validation, risk management, supplier qualification and auditing, product quality complaints, PQRs and Batch Record Review.
• Experience conducting internal and external audits and supporting Regulatory Authority inspections.
• Experience working with GMP, GDP and GVP requirements.
• Experience with batch release and Batch Record Review for medicinal products and Investigational Medicinal Products.
• Experience preparing, reviewing and approving pharmaceutical quality documentation, including SOPs, Technical Reports, Quality Agreements, Specifications and Product Specification Files.
• Experience with regulatory submission documentation and Module 3 requirements, including manufacturing process documentation and IMP documentation.
• Strong knowledge of EU GMP requirements, including Annex 13 and Annex 16.
• Knowledge of Italian pharmaceutical regulatory requirements, including Italian Legislative Decree 219/2006.
• Knowledge of the quality and regulatory requirements relating to Medical Devices and Combination Products.
• Experience working within a customer-focused pharmaceutical manufacturing environment.
• Ability to work effectively with internal functions, Regulatory Authorities, customers, suppliers, distributors and external partners.
• Ability to remain current with regulatory developments and communicate relevant requirements across the organisation.