Press Room

Article / Jun 17, 2016

Quality Culture Wins Over Compliance

Pharma's Almanac, June 2016

The author (Guy Villax) presents his views about the latest update of FDA's guidance which includes quality culture.

It’s Official! FDA has introduced Quality Culture in its guidance – although still in draft, it signals a sea change at the agency. No longer will FDA focus solely on compliance. Pharmaceutical manufacturers will be recognized for excellent performance. Pharma companies that rely on contract service providers will be able to use Quality Metrics and New Inspection Protocol Project (NIPP) performance scoring to make better decisions when it comes to selecting CDMOs.

Read Quality Culture Wins Over Compliance.

Also in the Press Room

See All

In an interview with Executiva, a portuguese media outlet focused on women´s leadership, Diane Villax, co-founder and long-standing leader of Hovione, reflects on her journey and the company’s development over more than six decades. Diane Villax’s career began at a time when few women worked outside the home. At 19, she joined a trading company as a foreign languages correspondent, where she developed essential business skills — including commercial correspondence, banking and export procedures — that later proved instrumental in helping her husband, Ivan Villax, establish Hovione in 1959. From its earliest days operating in the family home in Lisbon, Hovione adopted an international outlook. The company’s first major customers were in Japan, setting demanding quality standards that helped shape its long-term position in global markets. Over the following decades, Hovione expanded its footprint with the construction of its first manufacturing site in Loures (1969), followed by expansion to Macau (1986), the United States (New Jersey, early 2000s) and Ireland (Cork). The company grew into a global organization with more than 2,500 employees — including over 300 scientists — and a reputation as a preferred supplier to leading pharmaceutical companies worldwide. Throughout the interview, Diane highlights the values that have guided the company’s development: a commitment to excellence, a strong work ethic, and a focus on quality and long-term relationships. Although she did not have formal business training, she learned “on the job” and brought discipline, precision and structure to her role — particularly in the company’s early financial and administrative leadership. Now in her nineties and an active member of Hovione’s Board of Directors, Diane Villax remains engaged with the company’s evolution and governance, reflecting a continued commitment to its long-term development. Her story reflects entrepreneurial drive, resilience and long-term leadership — and offers insight into the values that have shaped Hovione’s trajectory for more than six decades. Read the full interview at Executiva.pt (in portuguese).    

Article

Hovione’s Diane Villax: “I was not brought up to be a business woman”

Feb 23, 2026