Compliance & Innovation Director

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.

Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.

The Director of Compliance & Innovation will be responsible for the global compliance Strategy and oversight across Hovione´s network, ensuring the highest GMP standards and regulatory readiness either for the current or new business areas.

This is a new role that will strengthen our global compliance profile, drive inspection readiness, and support the integration of new business modalities – particularly in biotechnology and aseptic manufacturing.

The ideal candidate brings a deep understanding of pharmaceutical quality systems, advanced knowledge of GMP compliance (EU, FDA, ICH), and a strong technical background in aseptic manufacturing and biotechnology.

• Provide strategic compliance leadership across all sites and business areas, ensuring adherence to EU, FDA, and ICH requirements.
• Develop and maintain the Global Compliance Framework, including risk management, audit readiness, and escalation processes.
• Oversee regulatory inspection strategy and readiness and act as corporate lead during health authority inspections.
• Ensure consistent interpretation and implementation of new or evolving regulatory expectations (e.g., Annex 1, data integrity).
• Partner with senior Quality and Operations leaders to embed compliance principles into current and new business modalities, and technology platforms. Lead targeted compliance improvement initiatives, driving a culture of quality, accountability, and continuous improvement.

• • Advanced degree in Pharmacy, Biotechnology, Biology, Chemistry, or related Life Sciences field.
  • Quality/Compliance experience in the pharmaceutical or biotechnology industry, ideally within a CDMO or multi-site environment.
  • Deep understanding of aseptic manufacturing and biological product operations.
  • Demonstrated success leading regulatory inspections (EMA, FDA, other major agencies).
  • Strong command of global GxP and data integrity principles.
  • Proven ability to assess compliance risks, implement corrective strategies, and influence at executive level.

Hovione is a proud Equal Opportunity Employer

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.

Notice to Agencies and Search Firms Representatives
Hovione 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.