Serialization Process Specialist (Supply Chain)

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

Job Description Summary

Serialized Product Traceability encompasses a set of Serialization and Track & Trace initiatives aimed at securing our supply chain to ensure safe, authentic products reach every patient, every time. The Serialization Process Specialist is accountable for ensuring accuracy and completeness of all Serialization transactions as part of the serialization program at Endo USA, Inc. The individual will be part a fast-paced team seeking to comply with a rapidly evolving landscape of global serialization regulations as well as leveraging new capabilities to improve the way Endo makes and delivers products to patients. This role will interact with a wide range of business functions to manage transactions, resolve transactional errors, understand processes, improve capabilities, and deploy new technologies quickly and effectively.
This role will be accountable for responding to verification requests of data scans ensuring that verification requests are legitimate. This role will support the management of serialization efforts with our customers, internal manufacturing sites, and Contract Manufacturing Organizations (CMO’s) in a timely and professional manner.

Job Description

Scope of Authority

Enterprise-wide maintenance of Serialization Activities within the Global Supply Chain function.

Key Accountabilities

Serialization

• Proactively monitor the systems daily to avoid delaying product release to market.
• Identify any gaps and suggest improvements based on industry best practices.
• Maintain procedures and compliance with serialization regulations in a timely fashion.
• Assist in investigating and verifying negative responses to salable return verification requests.
• Support the development and implementation of process and procedures to exchange serialization data with downstream partners.
• Onboard new partners and products for exchange of serialization information.
• Troubleshoot serialization related issues. Formal investigation of support issues, communication with impacted stakeholders, vendors, resolution/closure of the issue, and updating appropriate knowledge management records.
• Support evaluation and development of internal and external SOPs to ensure compliance with current and future DSCSA requirements.
• Manage master data to ensure accurate data exchange with upstream and downstream trading partners.

70%

Collaboration

• Collaborate with external Supply Chain partners (CMO's, 3PLs, Wholesalers, Customers) for real time visibility to support serialization activities.
• Communicate effectively and build cooperative and supportive working relationships across the wide range of functions involved in ensuring compliance to applicable regulations.
• Communicate and interact regularly and comfortably across various departments, from individual(s) to discuss solutions that foster strong relationships and continued success of the project.

30%

Qualifications

Education & Experience

• Bachelor’s degree in business, Supply Chain, Information Technology, or similar subject area.
• 1-3 years of relevant experience.

Knowledge

• Work experience in pharmaceuticals and/or manufacturing environments.
• Knowledge of the Drug Supply Chain Security Act (DSCSA) requirements.
• Experience using TraceLink preferable.

Skills & Abilities

• Coordinate and conduct regular stakeholder meetings. 
• Track project deliverables using appropriate tools.
• Ability to identify issues and risks and, in conjunction with the stakeholders, formulate plans to mitigate risks.

Physical Requirements

• Standard office environment.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.