Join a Market Leader:

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?

You will be responsible to::

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