Manager, Product Security

At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional business results.

Everyone at Astellas has a responsibility for creating a brighter future for patients around the world. From the first moment, Astellas will inspire you to put this ethos into practice – with a positive, agile company culture and with well-defined ethical principles, values and systems.

Everything we do is led by our company values of integrity, being patient centric, taking ownership, delivering results and communicating openly. These values are essential to Astellas’ relationship with its employees and now is an exciting time to join us as we continue to evolve as a cutting-edge, value driven life sciences innovator.

Purpose of the role:

Acts as liaison and subject matter expert on product security, overseeing the implementation of anti-counterfeiting programs and ensuring compliance with Astellas' supply chain security requirements both internally and externally.

This role involves educating stakeholders on product security protocols, assessing intelligence related to potential illicit activities, and managing third-party investigators, including contracts and performance.

What you will do includes:

• Leads Packaging Security Features implementation for relevant Astellas products.
• Responsible for overseeing compliance of Astellas internal groups and affiliates with global product security policies and procedures.
• Leads establishment and implementation of product security policies and procedures.
• Ensures compliance with current legislation related to counterfeit and/or falsified medicines, such as in Good Distribution Practices (GDP), the EU Falsified Medicines Directive or the US Drug Supply Chain Security Act, and similar.
• Monitors virtual and physical marketplaces for suspicious activities involving Astellas products.
• Conducts/arranges market surveys/sweeps in areas with high risk of illegal medicine trade.
• Leads internal/external investigations of potential illicit activities involving Astellas products (counterfeiting, falsification, theft, diversion, etc.) and conducts or supports audits as required.
• Takes ownership of continuously promoting the highest levels of security awareness & sensitivity.
• Develops and delivers training to colleagues, law enforcement, customs, health authorities and/or regulatory agencies, as required and appropriate.
• Collaborates with stakeholder departments including, but not limited to: Supply Chain, Quality Assurance, Regulatory Affairs, Intellectual Property, Legal, Corporate Communications, Pharmacovigilance, T&M, Astellas Group Plants or CMO’s.
• Collaborates with peers in other regions for global Product Security initiatives.

What you will need :

• Entry-level knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and other applicable regulations set forth by jurisdictional regulatory/health authorities.
• Ability to work autonomously in a matrixed environment with minimal supervision.
• Bachelor’s degree in related field from an accredited college or university or equivalent combination of education and experience.
• Experience working in manufacturing and/or distribution environments.
• Business proficient in English and at least one relevant Asian language.

Preferred Qualification:

• Experience in corporate/industrial security, intelligence analytics, quality assurance, supply chain/logistics or similar field(s).
• Experience working in a highly regulated industry (food, drugs, cosmetics, etc.).
• Formal training in investigations, auditing or similar.
• Proficient in speaking and writing Chinese language for business related requirement.