Job Description

One of our pharmaceutical clients is looking to hire a Sr. Cold Chain Supply Specialist to join their growing team. This team manages the pharmaceutical external manufacturing network, collaborating closely with Partnerships & External Supply, External Quality, Technical Operations, Planning, and Procurement to ensure reliable product delivery and customer service. The team is the supply chain node that supports internal processes for External Suppliers and ensures compliance for Change Control, Serialization and Training.

Essential Job Duties and Responsibilities

The Sr. Cold Chain External Supply Specialist will lead and support the development of data and execution of Cold Chain Critical Quality Systems. This role includes oversight of change control, event and CAPA management, training curricula development, and document lifecycle management.

Change Control and Investigations- This position will partner with multiple functions within the supply chain to collaboratively develop execution strategies to map the current Cold Chain processes and facilitate the change management process for Contract Management Operations (CMO) to Third Party Storage Locations (3PL). This role will serve as DRI (directly responsible individual) for managing change and supplier investigations in the quality system- driving timely implementation and closure of change controls while ensuring compliance to applicable quality standards and change control procedures.

Key tasks include:

-Lead the preparation, review, processing, approval, and closure of Change Controls

-Collaborate with business partners, Technical Lead Integrators, Value Chain Management, Quality, and External Partners to ensure relevant data is acquired for successful CC Closure

-Ensure Integrity, Consistency, and compliance of processes

Training- This position is responsible for ensuring training program compliance to Quality standards, GxP requirements, and Global Training Procedures for the Cold Chain team.

Key Tasks include:

-Training Key Performance Indicator (KPI) monitoring ensuring on time completion is >95%

-Development of Cold Chain onboarding program

Document Management- as a document specialist this role will ensure the Cold Chain team is compliant to Global Standards and managing the lifecycle management of Cold Chain Documents.

Tasks include:

-Global Document Gap assessment review in relation to Cold Chain

-Creation, revision, and obsoletion of Cold Chain Controlled documents in the TruVault System

-Approver Cold Chain documents as an author and subject matter expert for Cold Chain

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Skills and Requirements

-3 years experience in change control management within a regulated environment

-Previous exposure to cold chain operations

-Experience working with CAPAs in relation to logistics

-Ability to manage and approve design and partner sourcing effectively.

-Demonstrated ability to work independently

-Strong attention to detail

-Excellent organizational skills

-Excellent written and oral communication skills, with the ability to communicate clearly and professionally with internal and external clients, and tailor communication style to diverse audiences

-Flexible and able to adapt to changing needs, priorities, and scopes -Trackwise, Comet, Summit, Truvault experience

-Proven experience in training and curriculum development within quality systems. null

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.