SeniorFull TimeEN
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?
Ensure full compliance with cGMP, GDP, and regulatory requirements across product lifecycle activities, acting as the ultimate authority for batch certification and release. Drive a strong quality culture, safeguard patient safety, and enable business continuity through effective quality oversight and decision-making.Quality & Compliance Leadership
• Ensure compliance with GMP, GDP, ICH guidelines, and applicable global regulations across all activities.• Act as the legal Qualified Person, making final decisions on batch certification and product release.• Promote a strong Quality Culture and continuous improvement mindset across the organization.• Represent the company in interactions with Health Authorities and clients.
Product Quality Oversight
Regulatory & Stakeholder Management
Oversee key quality systems, including:
Supplier & Supply Chain Quality
Leadership & Decision-Making
• Solve complex quality issues with high autonomy and accountability• Manage risk, anticipate challenges, and prevent deviations• Coach and support teams to achieve high performance and compliance standards
• Team management
HSE & Compliance
• Ensure compliance with Health, Safety & Environment (HSE) policies• Actively contribute to a safe and sustainable working environment________________________________________
Additional Responsibilities
Drug Substance (API)• Certify that all API batches meet: o EU GMP and international standardso Applicable regulatory requirements and DMF commitments• Authorize release of APIs for commercial and investigational useDrug Product / IMP• Certify that all medicinal products comply with: o EU Directives and GMP requirementso Marketing authorization or product specification files• Authorize release/certification of: o Finished productso Investigational medicinal productso Intermediates
Degree in Pharmaceutical Sciences
Registered as Specialist in Pharmaceutical Industry (Ordem dos Farmacêuticos)
Qualified Person status (preferred)
5+ years in the pharmaceutical industry (API and/or Drug Product)
Experience across at least two areas:
Production
Quality Control
Quality Assurance
Materials Management
Proven experience interacting with regulatory authorities (e.g., FDA, INFARMED)
Experience in multinational/global environments is a plus
Strong knowledge of:
cGMP, ICH, CFR, and applicable legislation
Solid understanding of:
Pharmaceutical manufacturing and lifecycle management
Quality systems and regulatory frameworks
Strong decision-making and problem-solving skills
Excellent communication, negotiation, and stakeholder management
Ability to manage complexity, risk, and ambiguity
Fluent in English (written and spoken)
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 RepresentativesHovione 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.
