Qualified Person

At Hovione, we help partners turn scientific innovation into medicines that reach patients around the world. For more than 65 years, we have connected science and technology to scale complex ideas into high-quality and innovative solutions that truly make a difference.

As an international Contract Development and Manufacturing Organization (CDMO), we support the development and manufacture of drug substances, intermediates and drug products across the full life cycle. We are globally recognized for our leadership in specialized technologies such as Spray Drying and Continuous Tableting. But what truly sets us apart is not just what we do — it is how we do it: with purpose, care, collaboration and a deep commitment to doing the right things right.

Our people are the reason for our success. We are a global and diverse team of more than 2,600 team members across Europe, the USA and Asia, bringing together different experiences and perspectives to help our partners to overcome complex challenges. We believe that an inclusive environment — where everyone, regardless of background, identity or ability, is respected, heard and empowered to contribute — is essential to drive innovation, ensure quality, and secure long‑term sustainable success.

And as we grow, so do the opportunities for our people to develop, broaden their perspectives and build meaningful careers. Because at Hovione, better starts with those who choose to make a difference every day. Will you be one of them?

Guarantees cGMP compliance in all activities and systems related to Projects and Products execution. Assures that working practices are streamlined and aligned with the actual needs of each project. Implements policies, procedures and methods to evaluate and to continuously improve the quality of products and operations throughout the products lifecycle. Provides global supplier qualification services in support of new product introduction and existing products. Collaborates with suppliers and Procurement to assure the quality of their products, materials, components and/or operations.

• Ensures compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) guidelines and regulations. 
• To ensure that product quality related issues (e.g., recall, quality defects) are notified to the Customers or Health Products Regulatory Authority (as applicable) when product quality issue is of sufficient magnitude to affect the quality/ safety or efficacy of the product. 
• To promote a Quality Culture and Continuous improvement of standards, through the constant oversight of all applicable Quality guidelines and regulations. 
• Manages and coordinate the QP objectives and assure that they are in line with the company strategic plan.
• Communicates the quality and regulatory requirements to the different areas of the company. 
• Acts as point of contact and communication of quality issues with the Health Authorities and clients. 
• Represents Hovione in meetings with Regulatory Authorities and clients. 
• Provides technical support to internal and external customers on product quality related questions. 
• Assures that change control procedures consider regulatory marketing authorization implications, especially for critical changes requiring pre-approval, and to inform clients. 
• Assures and promotes compliance on Health, Safety and Environment in the areas and activities for which is responsible, or in which participates. 
• Act as decision maker in topics related to legal responsibility of the Qualified Person. 
• Solve complex problems with full autonomy. 
• Make quality and timely decisions based on multiple sources of data and regarding a wide array of subjects. 
• Manage risk and uncertainty; anticipate and address roadblocks in order to prevent deviations to the goals. 
• Coach project team members to enhance company effectiveness and promote achievement of high standards within the organization.
• Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione´s policies, systems and procedures (COPs, HBR, SOPs and others). 
• The following tasks may be delegated, but the QP should have an oversight on them: -Supplier Quality Management - Transparency of the entire supply chain
• Involvement in audits and their reports to enable signature of the QP-Declaration Template
• Source and specifications of starting and packaging materials 
• API manufactured according GMP 
• Excipients manufactured under appropriate GMP 
• Batch Record Review 
• Master Batch Records 
• Validation of all manufacturing and testing processes 
• Validation Master Plan 
• Change Control 
• Rework and Reprocessing
• Deviations and investigations 
• Investigation of complaints and adverse events 
• Investigation of a quality defect or recall 
• Access to reference and retention samples 
• Stability studies and ongoing-stability data 
• Approval of Quality Agreements -Self-inspection program 
• Participation in Quality Management Review 
• Approval of Annual Product Quality Reviews
• Involvement in implementation and maintenance of the Pharmaceutical Quality Management System 
• QP may delegate tasks but can only delegate responsibilities to another QP (registered at the relevant authority). 
• Specific additional responsibilities may depend on the specific type of products manufactured, as listed below. 
• Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice. Additional Responsibilities for Drug Substance: 
• Assure that every batch of active substances (APIs), both human and veterinary use, was manufactured and checked according to the quality requirements of the company, EU Good Manufacturing Practices, local legislation in force, International Guidelines (as applicable) and whenever applicable in accordance with the relevant marketing authorization and/or drug master file. 
• Accomplishment of the local and international legislation applicable to the manufacture of active substances for use in the pharmaceutical industry (both human and veterinary use). 
• Coordinate the approval and authorizes the release of the APIs for medicinal products in order to assure that the GMPs and, whenever applicable, the provisions of the marketing authorisation and/or drug master file are applied (for both human and veterinary use). Additional Responsibilities for Drug Product:
• Assure that every batch of medicinal products (MPs) or investigational medicinal products (IMPs), both human and veterinary use, was manufactured and checked according to the quality requirements of the company, EU Good Manufacturing Practices (as per EU Directives 2001/83/EC, 2001/82/EC, 2003/94/EC), local legislation in force, International Guidelines (as applicable) and whenever applicable in accordance with the relevant marketing authorization/product specification file.
• Accomplishment of the local and international legislation applicable to the manufacture of Investigational Medicinal Products and Medicinal Products (both human and veterinary use). 
• Coordinates the approval and authorizes the release/certification (as applicable) of the IMPs, MPs and intermediates for medicinal products in order to assure that the GMPs and, whenever applicable, the provisions of the marketing authorisation/product specification file are applied (for both human and veterinary use).

• University degree in Pharmaceutical Sciences with the title of Specialist in Pharmaceutical Industry by the Ordem dos Farmacêuticos.
• More than 5 years’ experience in the Pharmaceutical Industry (APIs and/or Drug Products) in at least one of the following areas: Production, Quality Control, Quality assurance or Materials Management. 
• Experience of working in more than one Operational Area, or within a multinational pharmaceutical company (desirable). 
• In depth knowledge on cGMPs, ICH guidelines, CFR and national and international legislation related to active pharmaceutical ingredients and pharmaceutical products.
• Good understanding on Company’s business and pharmaceutical industry competitive landscape. 
• Good global Company insight.
• Proved leadership and management skills. 
• Ability to identify and resolve complex quality issues 
• Negotiation, communication, and presentation skills. 
• Accuracy and attention to detail.
•  Ability to analyze, integrate and synthesize relevant information.
• Advanced spoken and written English. 
• Computer literacy and skills as a user for the software implemented in the company and related to the working area. 
• Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down. 

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. We are committed to creating an inclusive recruitment experience and welcome applications from all qualified candidates. If you require any reasonable accommodation or support during the application or interview process, please contact us, and we will be happy to assist.

Notice to Agencies and Search Firms Representatives
Hovione does not accept unsolicited résumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral. Thank you for your understanding.