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Associate Director, Serialization & Quality
Ref No.: 18-06584
Location: New Brunswick, New Jersey

Provide leadership for establishing company Authentication and Track & Trace processes and systems to help ensure regulatory compliance, to develop company capability to share and exchange trade and product information with its Authorized Trading Partners (ATP), Reverse Logistics Vendor, and regulatory authorities; and to identify additional business value/opportunities for company Operations and Product Surety/Illegitimate and/or Faslified Medicinal Product Strategy.

MAJOR DUTIES AND RESPONSIBILITIES

1. Lead the Authentication / Track & Trace Work Stream of the Serialization PMO for successful implementation of appropriate processes and systems.
2. Participate in the Serialization PMO and Country meetings.
3. Formulate and interpret policy and laws/regulatuions for company authentication and Track & Trace efforts.
4. Develop sustainabllity strategy for serialization in support of authentication and track & trace including:
• Product Authentication
• Track & Trace Plan
• Alignment with U.S. Trade Sales on ATPs relative to serialization / Track & Trace technology, Business to Business process, contractual agreements and authentication / Track & Trace pilots.
• Management of HealthAuthority access to company authentication and Track & Trace data/ information.
5. Support the company Product Surety/Illegitimate and/or Faslified Medicnal Product Strategy in various assigned activities/projects.
6. Participate in external industry organizations, identifying and communicating to management key points/issues.
7. Identifies and recommends appropriate actions, activities and projects for continuous improvements.
8. Perform other dueites as assigned.
Education:
1. BA/BS degree
2. Project management Training / certification
Experience / Knowledge Desired:
1. Minimum 15 years experience in the Pharmaceutical Industry with 5 years in a Quality Function/Role
2. Supply Chain, distribution, Product Transportation, Pedigree/Traceability, Anti-counterfeiting technology, returns and recalls
3. Leading and supporting projects of a Global nature and management of Quality related issues.
4. Project Manager/ Program Manager
5. Development and Implementation of Policies, Directives, SOPs and Best Practices.
6. Contract / Vendor Management
7. Technical expertise; SAP, Business Planning and Control Systems, Inventory management Systems, Quality software/tools.
8. Current Industry knowledge on anti-counterfeiting and supplychain security strategies, technologies and practices.
9. Leadership skills
10. Influencing and negotiation skills
11. Critical thinking, a decisive manner and ability to remain calm under adverse events.

10% of traveling required to attend industry meetings as well as company facilities or contracted service providers.
Overnight absences required.
Additional Job Requirements:
None