Associate Director, Regional Product Security
- Celgene Corporation
- Date de publication
Associate Director, Regional Product Security
Within the assigned region, this position plays a key role in supporting the Global Product Security Programs by leading, developing, promoting and aligning regional management, procedures and activities to enforce global policies and requirements. Collectively, these regional / local actions will support the effective and efficient protection of Celgene products and operations and support our commitment to protect patient safety.
Within the assigned region, this position plays a key role within Global Pharmaceutical Development & Operations and has four primary areas of responsibility:
- Supply Chain Security which implements regional practices and policies to promote the secure storage, handling, movement and disposition of product and materials throughout the global supply chain; conducts audits and assessments to ensure compliance with Celgene requirements; and, conducts investigations and due diligence assessments related to Supply Chain Security;
- Support Brand Protection investigations and activities to proactively and reactively monitor potential illegal diversion, counterfeits and other brand protection related threats;
- Assist the Anti-Counterfeiting Program which uses strategies, technology, application techniques and monitoring methods to allow authentication of legitimate Celgene product throughout the global supply chain;
- Regional Security oversight for Celgene and third party GxP facilities in the International region.
- This position will report solid line to the Senior Director, Product Security & Integrity and have dotted line responsibility to the Head of Manufacturing - Couvet, Switzerland.
- The successful candidate must excel at working in a collaborative, cross functional, diverse, complex, resource-constrained environment and be able to drive decision-making processes that involve multiple constituencies and constraints.
Responsibilities will include, but are not limited to the following:
Strategy and Practices
- Execute against the strategic and operational security objectives developed by Global Product Security to ensure the security and integrity of Celgene materials.
- Develop harmonized policies, SOP's, work practices, to support global requirements for both internal/external parties by leading cross-functional internal/external teams in all areas and countries of responsibility.
- Engage actively with senior management to support product security initiatives in the assigned areas; engage as the subject matter expert for product security matters.
- Conducts audits and assessments to ensure compliance with Celgene requirements, government regulatory requirements and trade compliance programs.
- Develop, deploy and monitor corrective and preventative actions to ensure mitigation activities are enacted properly and results achieved.
- Harmonize host Governmental Supply Chain Security Programs (Ex. AEO) with global supply chain security requirements; oversee compliance with programs.
Investigation Support and Event Response
- Investigate all supply chain integrity matters / violations and fully document findings.
- Support Brand Protection investigations as required including investigations of all counterfeit and illegal diversion matters; where appropriate, prepare investigations for law enforcement referral.
- Conducts due diligence activities with appropriate affiliate stakeholders (i.e. Logistics, Operations, QA, and Supply Chain) to provide security input regarding the selection of Celgene and 3rd party supply chain sites.
Conduct "For Cause" audits for high risk suppliers.
- Respond to identified emerging threats to supply chain security as well as related country/region specific regulations.
- Support regional implementation of anti-counterfeiting program including vendor selection, regulatory compliance, internal / external execution, project management and fiscal responsibility.
- Integrate product protection programs and processes into regional company businesses in order to ensure sustainable brand protection results and best practices.
- Support the use of anti-counterfeiting features downstream in the supply chain to implement authentication strategies and practices to confirm legitimate Celgene materials.
- Create security feature authentication awareness and training programs for both internal parties and external law enforcement and customs officials.
Regional Security Support
- Support regional intelligence gathering and monitor efforts of emerging threats to supply chain security as well as related country/region specific regulations.
- Provide regional management with timely, reliable and well-structured information regarding product security initiatives including tracking of KPI's, variance analysis and contingency plans for corrective measures.
Subject Matter Expert
- Promote product security awareness and knowledge with all internal and external groups. Ensure supply chain team is fully trained in required supply chain security policies and programs. Document required supply chain security training.
- Report local intelligence to Global Analyst; provide regular updates to Global Product Security and regional management.
- Develop and maintain a network of knowledgeable and influential persons in government, law enforcement, security, intelligence, and internal functions.
- Remain current with security industry practices, trends and technologies. Identify key supply chain security trends and technologies that might be leveraged to protect and improve commercial supply chain operations.
- Bachelor's degree in criminal justice/business administration/ supply chain/ legal or a related field.
- Minimum 10 years' experience in security or law enforcement. Prior experience in criminal justice and/or investigations related to diversion, theft, product tampering, product counterfeiting, fraud, etc. is a plus.
- Supply chain security experience requested preferably in the pharmaceutical industry.
- Superior verbal/written communication abilities.
- Ability to champion new ideas or positions to meet key goals and initiatives.
- Strong commitment to patient safety and compliance requirements.
- Basic understanding of commercial pharmaceutical operations and related supply chains including regulatory requirements (i.e. GxP, Track & Trace, etc.).
- Superior audit and investigative skills to evaluate supply chain security risks as well as security program compliance.
- Must possess the ability to be a self-starter and work independently with internal and external groups on multiple simultaneous projects.
- Willing to travel 30 - 50% domestically and internationally occasionally on short notice.
- Position is located in Couvet, Switzerland