Supplier Quality Operations Senior Manager

<p>Pharmathen is one of the leading complex drug delivery and formulation developers and is among <strong>the top 50 pharmaceutical research companies</strong> in Europe. Driven by innovation, the company specializes in one of the most modern and technologically innovative sectors, developing Long Acting Injectables (LAI), Sustained Release formulations and Preservative Free Ophthalmics.</p> <p>Pharmathen’s portfolio consists of <strong>over 100 products</strong>, produced at its facility in Sapes, Rodopi, approved by the US Food and Drug Administration (FDA), and at its modernized production unit in Pallini, Attica.</p> <p>Pharmathen is one of the largest private investors in research and development in Greece, with steady investments of €35 million annually in the R&amp;D sector and employs over <strong>1,350 people</strong> from over <strong>24 different nationalities</strong>. The company's enduring success is attributed to the passion for creativity, the ethics, and dedication of its people, who share the company's vision of making a difference in people’s lives.</p> <p>Due to continuous growth and expansion, <strong>Pharmathen Pharmaceuticals</strong> offers a great opportunity for career development and is seeking to recruit a <strong>Supplier Quality Operations Senior Manager</strong> for the Corporate Quality Management department at our <strong>Pallini premises</strong>.</p> <p>As a<strong> Supplier Quality Operations Senior Manager, </strong>the ideal candidate will act in the context of evaluating and ensuring compliance of our suppliers with the regulatory requirements, industry standards (GMP), Pharmathen and customer expectations. He/she will provide long-term cooperation strategies with our suppliers by aligning them with the Company’s Quality Policies and establish a stable, compliant, cost effective high performing quality relationship with Suppliers. He/she will build and operate a corporate structure that is responsible for establishing quality evaluation aspects of the production, storage and distribution of materials and supplies as well as the provision of services by suppliers.</p> <p>More particularly:</p> <p><strong>What you will do: </strong></p><p><strong>Requirements</strong></p><ul> <li>Ensure the compliance of the Suppliers Evaluation Requirements according to current pharmaceutical cGMP, Pharmaceutical Legislation, and International Standard ISO 9001</li> <li>Develop and / or review SOPs following the current pharmaceutical GMP providing guidance</li> <li>Review the authorship of departmental SOPs, TDRs, protocols, and any other kind of controlled quality document</li> <li>Supervise the vendors’ evaluation program applicable to all Pharmathen GMP divisions </li> <li>Maintain the GMP list of Pharmathen’s approved suppliers </li> <li>Ensure appropriate handling, monitoring, trending notification request of supplier’s complaints and coordinate execution of investigation reports, risk assessments and subsequently response to the affected customers</li> <li>Review complaint investigation reports and corresponding documents, including response letters, for accuracy and completeness</li> <li>Correspond with all departments on corrective actions after closing the complaints and follow-up</li> <li>Coordinate / participate in the product annual review providing information and data related to suppliers’ evaluation sections </li> <li>Coordinate and support compliance requests for quality assessment of our suppliers received from Authorities and Clients both for dossier submission and variation needs on a case-by-case basis</li> <li>Coordinate activities for the preparation, submission and follow up of the documentation related to suppliers’ evaluation</li> <li>Participate in new projects related to optimization procedures of Suppliers’ evaluation processes</li> <li>Participate in all special occasions in regard to the Corporate Quality Management needs and authorizations related to his /her position </li> <li>Participate in external Quality System Audits and inspections conducted by customers and competent Health Authorities to our suppliers if necessary </li> <li>Collaborate and provide support to external or third-party auditors during preparation and implementation of an audit to our suppliers as necessary </li> <li>Collaborate on the preparation, performing, and Corrective/Preventive Actions’ follow up of audits and other Pharmathen’s assessments to its suppliers</li> <li>Conduct audits to our suppliers in collaboration with SMEs if required </li> <li>Review and coordinate approval, through approved mechanisms, of specifications, Change Notices, Change controls, Deviations, and any other key document to ensure adherence to GMP and regulations</li> <li>Keep active involvement of the above to commercial and R&amp;D level </li>