Qualified Person

UNAVAILABLE; Loures; Presencial; EUR 90 000 - 130 000; Tempo integral

Resumo da oferta

Hovione in Portugal seeks a Quality & Compliance Leader to ensure cGMP compliance across product lifecycle and to authorize batch certification and release.

You will drive product quality oversight, regulatory interactions, continuous improvement, and a strong quality culture to safeguard patient safety and business continuity.

Qualificações

• 10+ years in the pharmaceutical industry (API and/or Drug Product).
• Experience with regulatory authorities (FDA, INFARMED).
• Proven ability to manage multiple QA functions (QA, QC, Production).
• Fluent in English (written and spoken).

Responsabilidades

• Ensure full compliance with cGMP, GDP, and ICH guidelines.
• Act as Qualified Person, approving batch release.
• Lead quality governance and continuous improvement.
• Oversee supplier and supply chain quality.
• Interact with Health Authorities and clients.
• Drive risk management and incident investigations.

Conhecimentos

Fluent in English

Decision making

Problem solving

Formação académica

Degree in Pharmaceutical Sciences

Registered Specialist (Ordem dos Farmacêuticos)

Descrição da oferta de emprego

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:

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

• Ensure all products (APIs, Drug Products, IMPs) are:o Manufactured and tested in compliance with regulatory requirementso Aligned with marketing authorizations and technical dossiers
• Oversee and approve:o Batch record reviews and releaseo Deviations, investigations, complaints, and recallso Change controls with regulatory impacto Annual Product Quality Reviews

Regulatory & Stakeholder Management

• Act as primary contact for quality-related communications with regulatory authorities and cliente
• Ensure timely reporting of quality defects, recalls, or critical issues
• Provide expert guidance on regulatory expectations and compliance strategies
• Quality Systems & Continuous Improvement
• Ensure effective implementation and maintenance of the Pharmaceutical
• Quality Management System (PQMS)

Oversee key quality systems, including:

• Validation (processes, methods, and systems)
• Stability programs
• Self-inspections and audit
• Drive improvements in quality processes and operational efficiency

Supplier & Supply Chain Quality

• Collaborate with Procurement and suppliers to ensure:
  • Compliance of APIs, excipients, and packaging materials
  • Robust supplier qualification and performance monitoring

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

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 use
• Drug 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

We are looking to recruit a Candidate:

• Degree in Pharmaceutical Sciences

• Registered as Specialist in Pharmaceutical Industry (Ordem dos Farmacêuticos)

• Qualified Person status (preferred)

• 10+ 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, pleasecontact us,and we will be happy to assist.