Astellas Global Quality Assurance is recruiting for a Product Security Manager to serve as the primary liaison and subject matter expert (SME) for routine product security-related issues and/or daily activities in assigned region(s).
Office based – Chertsey, Surrey, with some International travel
Reporting lines - Reports to the Director, Product Security whom is based in the U.S. There are no subordinate positions. Product Security reports 50% to Global Quality Assurance and 50% to Technology Division (AUST) so the function operates in a matrix reporting environment. Close collaboration with counterparts in Japan is required.
Your role as Product Security Manager
This role requires you to be accountable for ensuring compliance with all relevant SOPs/GSOPs as well as implementation and maintenance of programs/initiatives as assigned by the Director, Product Security.
This includes assessing incoming multi-source intelligence and initiates investigations as appropriate. Maintains oversight of 3rd party investigators including contracts, billing and performance. Overseeing anti-counterfeiting program for domestically manufactured/packaged products and tactically supports supply chain security activities.
The Manager, Product Security is accountable for regulating expenditures related to investigations, market surveys and travel. Accountable for performance of 3rd party vendors engaged in monitoring and investigative activities. Also accountable for ensuring audits and anti-counterfeit technology rotations are conducted in accordance with applicable schedules, policies, etc.
- Monitors virtual marketplaces for suspicious activities involving Astellas products
- Coordinates market surveys/sweeps in areas with high risk of illegal medicine trade
- Initiates and oversees investigations including vendor engagement, billing, etc.
- Oversees anti-counterfeiting activities in assigned region(s)
- Ensures compliance with current policies, practices and procedures
- Conducts internal and external security audits
- Develops and/or delivers training to law enforcement and/or regulatory agencies
- Leads or supports supply chain security activities
- Collaborates with peers in other regions for global Product Security initiatives
- Other related duties as assigned
Skills & Experience
- Bachelor’s Degree in related field from an accredited college or university and 5 - 7 years of experience in corporate/industrial security, intelligence analytics or similar field.
- Formal training in investigations, auditing or similar
- Experience working in manufacturing and/or distribution environments
- Ability to work varied hours to accommodate time zones in countries where related activities are ongoing.
- Occasional travel (domestic & international).
- Law enforcement or military background
- Experience working in a highly regulated industry (food, drugs, cosmetics, etc.)
- Working knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and other applicable regulations set forth by the Food and Drug Administration (FDA), and/or other health/regulatory authorities.
· A challenging and diversified job in an international setting
· Good career opportunities
· Inspiring work climate
· Attractive remuneration package