Qualified Person
About the job
- A degree in Pharmaceutical Sciences.
- Registration as a Specialist in Pharmaceutical Industry with Ordem dos Farmacêuticos.
- At least 10 years of experience in the pharmaceutical industry, in active pharmaceutical ingredients and/or drug products.
- Experience in at least two of the following areas: Production, Quality Control, Quality Assurance, or Materials Management.
- Proven experience interacting with regulatory authorities, such as the FDA or INFARMED.
- Strong knowledge of current Good Manufacturing Practices, International Council for Harmonisation guidelines, the Code of Federal Regulations, and applicable legislation.
- A solid understanding of pharmaceutical manufacturing and lifecycle management, quality systems, and regulatory frameworks.
- Fluency in written and spoken English.
- Strong decision-making and problem-solving skills.
- Excellent communication, negotiation, and stakeholder management skills.
- Ability to manage complexity, risk, and ambiguity.
- Ensure compliance with current Good Manufacturing Practices, Good Distribution Practices, International Council for Harmonisation 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.
- Ensure all active pharmaceutical ingredients, drug products, and investigational medicinal products are manufactured and tested in compliance with regulatory requirements and aligned with marketing authorizations and technical dossiers.
- Oversee and approve batch record reviews and releases; deviations, investigations, complaints, and recalls; change controls with regulatory impact; and Annual Product Quality Reviews.
- Serve as the primary contact for quality-related communications with regulatory authorities and clients.
- Ensure timely reporting of quality defects, recalls, or critical issues.
- Provide expert guidance on regulatory expectations and compliance strategies.
- Ensure effective implementation and maintenance of the Pharmaceutical Quality Management System.
- Oversee validation of processes, methods, and systems; stability programs; and self-inspections and audits.
- Drive improvements in quality processes and operational efficiency.
- Collaborate with Procurement and suppliers to ensure compliance of active pharmaceutical ingredients, excipients, and packaging materials, and to maintain robust supplier qualification and performance monitoring.
- 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.
- Ensure compliance with Health, Safety and Environment policies and contribute to a safe and sustainable working environment.
- Certify that all active pharmaceutical ingredient batches meet EU Good Manufacturing Practice and international standards, applicable regulatory requirements, and Drug Master File commitments.
- Authorize release of active pharmaceutical ingredients for commercial and investigational use.
- Certify that medicinal products comply with EU directives and Good Manufacturing Practice requirements, and with marketing authorizations or product specification files.
- Authorize release or certification of finished products, investigational medicinal products, and intermediates.
- Qualified Person status is preferred.
- Experience in multinational or global environments is a plus.
About the company
Hovione is a contract development and manufacturing organization that helps pharmaceutical companies develop and manufacture active pharmaceutical ingredients (APIs). It specializes in complex chemistry and manufacturing techniques such as particle engineering and spray drying to improve how drugs are absorbed. The company stands out through a long history, a focus on difficult-to-make compounds, and a global footprint with FDA-inspected sites in Portugal, Ireland, China, and the United States, built from a private, family-owned background. Its goal is to enable partners to bring new medicines to market efficiently by providing high-quality, scalable manufacturing capacity and continuous investment in capabilities.
Company Size
1,001-5,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Loures, Portugal
Founded
1959
Get referred to Hovione
See people who can refer or advise you
Simplify's Take
What believers are saying
- September 16, 2026, Hovione opened 89 Twin Rivers, doubling U.S. spray-drying capacity.
- March 2025's Seixal campus targets mid-2027 commissioning and fresh manufacturing capacity.
- April 1, 2027, Stefan Doboczky becomes CEO after Hovione's succession review.
What critics are saying
- May 11, 2026, Jean-Luc Herbeaux left; co-CEOs run Hovione until April 2027.
- Seixal's 2027 launch demands flawless execution after Loures reached physical limits.
- U.S. customers fund 60% of sales, so FDA delays hit 2026 growth immediately.
What makes Hovione unique
- Hovione owns spray drying, tableting, and drug-product manufacturing under one quality system.
- Its East Windsor and Loures campuses integrate amorphous solid dispersions with commercial-scale output.
- The 2026 intranasal platform pairs API development with patented device supply.
Help us improve and share your feedback! Did you find this helpful?
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Paid Vacation
Company News
Hovione to develop new continuous tabletting line. Published: 7 October 2026 CDMO Hovione is commissioning a continuous tabletting line called ConsiGma CDC Flex at its New Jersey campus in late 2027. The $35m project will be installed at Hovione's recently opened facility, 89 Twin Rivers. Once installed, it will create an integrated pathway from amorphous solid dispersion manufacturing via spray drying through commercial tablet production. Continuous tabletting is well suited to programmes in which speed, supply resilience and efficient use of high-value active pharmaceutical ingredients are crucial. "Hovione will be the first company in the world to offer the ConsiGma CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tabletting," said Hovione co-CEOs Marco Gil and António Almeida. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." ConsiGma CDC Flex will operate in continuous or batch modes across a broad throughput range of 1 to 200kg/h. Operators will be able to develop a formulation using quantities of material as small as 1.5kg, and then run from small clinical batches to large commercial batches with the same equipment. Specialised design enables the switch between continuous blenders of various sizes. The line will be installed for containment to 1 μg/m[3], supporting highly potent compounds. "Installing the CDC Flex at 89 Twin Rivers makes continuous tabletting part of an integrated U.S. development and manufacturing workflow," said David Basile, VP of Technical Operations, Americas for Hovione. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Developed jointly with GEA, the ConsiGma CDC Flex platform also incorporates SimpleCT, a suite of automation and control tools with smart interfaces that supports a single process from development to commercial supply.Inline process analytical technology and automated controls also provide real-time quality monitoring.
Hovione invests $35M in world's first ConsiGma CDC Flex tableting line. The next-generation continuous manufacturing platform will launch at Hovione's East Windsor, New Jersey, campus in late 2027. October 5, 2026 Associate Editor, Contract Pharma Editor's Take: As pharmaceutical companies strive to bridge scientific breakthroughs with practical delivery, oral solid dosage development and manufacturing has become a focal point for modernization. Global CDMO Hovione will commission the world's first ConsiGma CDC Flex, a next generation continuous tableting line, at its East Windsor, New Jersey campus in late 2027. The project represents an investment of $35 million. Once installed it will create an integrated pathway from amorphous solid dispersion manufacturing via spray drying through commercial tablet production. "Hovione will be the first company in the world to offer the ConsiGma CDC Flex, bringing this next-generation technology with unprecedented flexibility, simplicity and cost-efficiency in continuous tableting," said Marco Gil and António Almeida, co-CEOs of Hovione. "This investment also advances our strategy of building integrated capabilities close to customers in key markets. By adding this new line at East Windsor, we are broadening access to this technology in the U.S. and giving customers a more direct and accelerated path for developing and commercializing complex oral medicines." The new ConsiGma CDC Flex will operate in continuous or batch modes across a very broad throughput range (from 1 to 200 kg/h). Customers will be able to develop a formulation using small quantities of material, down to 1.5 kg, and then run from very small clinical batches to large commercial batches using the same equipment. This is enabled by specialized design within the ConsiGma CDC Flex to effectively switch between continuous blenders of various sizes. Additionally, the line will be installed for containment to 1 μg/m[3], supporting highly potent compounds. "Installing the CDC Flex at 89 Twin Rivers makes continuous tableting part of an integrated U.S. development and manufacturing workflow," added David Basile, Vice President of Technical Operations, Americas for Hovione. "Customers can move from formulation and particle engineering to commercial tablets with one Hovione team and one quality system, eliminating traditional scale-up while gaining greater production flexibility, process control and supply continuity." Developed jointly with GEA, the ConsiGma CDC Flex platform also incorporates SimpleCT, a suite of automation and control tools with smart interfaces that supports a single process from development to commercial supply. Designed for versatility and ease of use, these developments are designed to simplify operation, improve efficiency and containment, and enhance operator safety. Add us as a preferred source on Google. Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.
Hovione doubles US spray-drying capacity with opening of New NJ facility. This closes a $100 million investment cycle, and creates approximately 80 new jobs. September 16, 2026 Content Marketing Editor Editor's Take: Spray-drying can help create amorphous solid dispersions that turn poorly soluble drug ingredients into more bioavailable forms. Hovione opened a new, 31,000-square-foot facility on Sept. 15, located at 89 Twin Rivers on its East Windsor, NJ campus. Contract Pharma previewed this ribbon-cutting in July, after having gotten to tour Hovione's expanded operations in spring 2026. The new facility adds two commercial-scale PSD-3 spray dryers, both good manufacturing practice (GMP)-ready. As such, it doubles Hovione's United States spray-drying capacity, reinforcing the CDMO's global leadership in this type of technology. Importance of spray-drying. Hovione says approximately 70% of small-molecule drug candidates show poor aqueous solubility. This limits bioavailability and slows development. Amorphous solid dispersions, like those created through Hovione's specialized spray-drying platform, can turn poorly soluble ingredients into more bioavailable forms. Co-CEOs Marco Gil and Antonio Almeida say the expansion is a next chapter after Hovione's two decades-plus in the U.S. "This investment enables us to meet growing demand while further reinforcing our global leadership in pharmaceutical spray drying," they said. "Equally important, this technology sits within an integrated offering that extends from drug substance through drug product. [This gives] customers a more direct and resilient path from early development to commercial. This is how we help them address poor solubility, one of the industry's most persistent development challenges." Hovione committed to NJ. David Basile, Hovione Vice President of Technical Operations, Americas, calls the facility a "clear expression" of a long-term commitment. "Our growth is built on sustained investment in scientific expertise, technological innovation, advanced manufacturing capabilities, and talented people," Basile said. "We will continue to strengthen this site as an innovation hub for pharmaceutical development and manufacturing. [This contributes] to the competitiveness of New Jersey's life sciences ecosystem and to a stronger U.S. manufacturing base." The facility opening completes a $100 million investment cycle, and will employ approximately 80 people. However, Hovione plans to continue growing its U.S. operations, including in East Windsor, over the next decade. Add us as a preferred source on Google. Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.
Supplier news: AtomVie, CordenPharma, Hovione, Evonik & more. The latest from CDMOs, CMOs, and suppliers featuring AtomVie, CordenPharma, Northway Biotech, Hovione, Evonik and QPharma. Chemicals/Chemical API Manufacturing AtomVie Radiopharma Opens New $160-M Radiopharmaceutical Mfg Facility AtomVie Global Radiopharma, a CDMO focused on radiopharmaceuticals, has opened a new $160-million manufacturing facility in Hamilton, Ontario, Canada. The 72,300-square-foot facility features low-to-high throughput production and represents more than a tenfold increase in AtomVie's manufacturing capacity. The facility enables progression from early development to commercial manufacturing of radiopharmaceuticals, with customizable space dedicated to clients' future needs. Biologics Manufacturing Northway Biotech Opens $71-M Facility for Cell, Advanced Therapies Northway Biotech, a Vilnius, Lithuania-based CDMO focused on biologics, has opened a EUR 61-million ($71-million) cell therapy and personalized medicine center in Vilnius, Lithuania. The new 3,500-square-meter facility adds development and cGMP manufacturing capacity for advanced and personalized therapies. Northway Biotech's CDMO platform includes mammalian and microbial biologics, gene therapy, and cell-based technologies. Formulation Development/Drug Product Manufacturing CordenPharma Invests $93 M for Sterile Mfg Expansion CordenPharma in making a multi-year EUR 80-million ($93 million) investment for injectable drug products at is site in Caponago (Milan), Italy, with the EUR-13 million ($15 million) acquisition of a new 11,000-square-meter commercial building and 26,000 square meter of land, adjacent to its existing late-stage aseptic fill-finish manufacturing area. This expansion was finalized on July 28, 2026, increasing the site footprint by greater than 50%. The space can accommodate a minimum of four aseptic fill-finish lines, four visual inspection lines, and four additional packaging lines, with options for customer-owned lines, large-scale lyophilization, and auto-injector assembly. Secondly, over the past two years, CordenPharma has embarked on a series of strategic expansions at an existing operational area within its Caponago site that now contributes to the increased injectable capacity by adding two new aseptic fill-finish isolator lines. These include: * A clinical and small-scale commercial combo line from Bausch & Ströbel for prefilled syringes (PFS), vials, and cartridges. * A high-speed PFS and cartridge line from Syntegon, capable of producing >500,000 units per day. * Expansion of the automatic secondary packaging area for PFS, vials, and ampoules. * A doubling of analytical capacity to support growing project pipelines. Completion of the new isolator lines is targeted for mid-2027 and 2028, respectively. Appointments Hovione Names New CEO Hovione has announced the appointment of Stefan Doboczky, currently Chairman of the Board of Directors of Hovione, as Chief Executive Officer (CEO), effective April 1, 2027. Doboczky has served as Chairman of the Board of Directors of Hovione since 2024, where he has been instrumental in shaping the company's strategy and vision. He will step down as Chairman on assuming the role of CEO. The appointment marks a return to the pharmaceutical industry for Doboczky, who spent more than 17 years at Royal DSM, where he became a member of the Executive Board responsible for the group's global pharmaceutical portfolio and for its growth in Asia. He subsequently spent 11 years as CEO of listed, private-equity-owned and corporate-owned industrial companies, including Lenzing AG, Heubach GmbH, and Borealis AG. Following the combination of Borealis, Borouge, and Nova Chemicals into Borouge International, he took on the role of Chief Commercial Officer and Deputy Chairman of the Executive Board of the merged group. He will hand over these responsibilities to his successor on October 1, 2026, and remains available for six months to support the transition. Evonik Names Interim CEO Evonik has appointed Dr. Claus Rettig, currently the Head of Evonik's Asian business, as Interim CEO, taking over for Christian Kullmann, Evonik's current CEO, who is recovering in the upcoming weeks from a recent serious, unplanned surgery. Additionally, Rettig was appointed to Evonik's Executive Board, effective September 1, 2026, and has been appointed Deputy Chairman. Rettig has been with the company for more than 30 years and heads Evonik's Asian business as General Representative in Singapore. Until further notice, Rettig is taking over the duties of Kullmann and will continue his responsibility for Asia as member of the Executive Board. Sever Pharma Solutions Renames to QPharma Sever Pharma Solutions, a Malmö, Sweden-based CDMO specializing in polymer-based complex drug-delivery systems, sterile injectables, and high-potent processing, has changed its name to QPharma AB, effective September 1, 2026.
Hovione names Stefan Doboczky new CEO. Chairman of the Board of Directors Stefan Doboczky to take over operational leadership of the family-owned pharmaceutical technology and services group on April 1, 2027. Stefan Doboczky has served as Chairman of the Board of Directors of Hovione since 2024, where he has been instrumental in shaping the company's strategy and vision. He will step down as Chairman upon assuming the role of Chief Executive Officer. Founded in 1959, Hovione is a family-owned pharmaceutical technology and services group serving the industry worldwide, with more than 2,600 employees, four FDA-inspected production and R&D sites in Europe, the United States and China, and internationally recognized technology leadership in spray drying and continuous tableting. The appointment marks a return to the pharmaceutical industry for Stefan Doboczky, who spent more than 17 years at Royal DSM, where he rose to become a member of the Executive Board responsible for the group's global pharmaceutical portfolio and for its growth in Asia. He subsequently spent 11 years as CEO of listed, private-equity-owned and corporate-owned industrial companies, including Lenzing AG, Heubach GmbH and Borealis AG. Following the combination of Borealis, Borouge and NOVA Chemicals into Borouge International, he took on the role of Chief Commercial Officer and Deputy Chairman of the Executive Board of the merged group. He will hand over these responsibilities to his successor on October 1, 2026 and remains available for six months to support the transition. Stefan Doboczky holds a Master's degree in technical chemistry and a doctorate in natural sciences, both from Vienna University of Technology (TU Wien), Austria, and an MBA from IMD, Lausanne, Switzerland. The appointment follows a comprehensive succession process conducted by the Board of Directors and marks an important step in the continued development of Hovione. The appointment reflects the company's ambition to further strengthen its international position as a leading technology and service provider to pharmaceutical companies worldwide. Guy Villax, Non-Executive Director and Chair of the Family Council, representing the company's major shareholder, said: "We are very pleased that Stefan is taking on the operational leadership of Hovione. Having served as our Chairman, he has an in-depth understanding of the company, its culture and its people, and has co-shaped our strategic direction and priorities. His international experience, his commercial expertise and his proven capability to transform companies sustainably make him exceptionally well positioned to lead Hovione into its next phase of growth. That he is willing to move from the Board into the operating seat is a strong signal of his conviction in this company and in the opportunity ahead of it." Stefan Doboczky, Chief Executive Officer designate of Hovione, said: "I am honored to take on the role of CEO at Hovione and to move from my role as Chairman of the Board into the operational leadership of the company. In my two years as Chairman, I have come to see the remarkable potential of this organization, built on a very strong technology foundation, talented people and a genuine focus on patients. Returning to the pharmaceutical industry, where I spent the formative part of my career, and doing so as the CEO of a family-owned company with such a long-term horizon, is a unique opportunity. I thank the Board and the shareholders for their trust. I look forward to working closely with Hovione's global leadership team and the Board to strengthen our international presence, drive innovation and create sustainable value for our customers, partners and shareholders." The Board also expressed its appreciation to Marco Gil and António Almeida for their ongoing leadership during the interim co-CEO period and for ensuring the continued successful execution of the company's strategy until Stefan joins as CEO. Company. Sete Casas 2674-506 Loures Portugal