Senior Quality Systems Specialist

About Hovione

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, technology, and manufacturing 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?

Act as the company's Subject Matter Expert (SME) for:

• Process Validation
• Cleaning Validation
• Contamination Control Strategy
• New Product Introduction
• Regulatory segregation requirements for the manufacture and handling of highly active, potent, toxic, sensitizing, and other special-category compounds

You will also be Responsible to:

• Promote the importance of high-quality work levels and the importance of a continuous improvement culture in all Quality and/or Regulatory Systems activities
• Open and maintain active and efficient communication channels along the several Hovione Sites, identifying Quality or Regulatory needs and improvements
• Evaluates, advises and provides services and technical support related to the legal and scientific regulatory requirements associated with product development, commercialization, and optimization throughout the full product lifecycle
• Manage complex projects/ analysis with significant impact on business
• Lead initiatives with other departments, ensuring plan definition and timely execution
• Make quality and timely decisions based on multiple sources of data
• Master Quality Systems’ processes, tools, related documentation, and training

This position is focused on enterprise-wide leadership, technical expertise, and strategic influence, with responsibility for shaping quality standards and practices, guiding risk-based decision-making, and driving alignment and consistency across the Hovione network.

Education

- University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmacy or similar scientific field (mandatory)

- Advanced knowledge of Quality and/or Regulatory requirements, cGMP´s, ICH, CFR, EU, local or any other as applicable guidelines and ISO Standards

- Fluency in English is a requirement

- Computer literate with good working knowledge of the MS Office package

Experience

-5 to 10 years of relevant overall experience in at least 2 operational and support areas (e.g.: Quality Control, Quality Assurance, Manufacturing, R&D, Engineering)

- Understanding of the business and managing complex projects/ analysis with significant related impact

- Knowledge of industrial safety and application of lean6sigma and risk assessment tools to GMP operations

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 resumes 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.