What are the responsibilities and job description for the Pharmaceutical SME Warehouse/Distribution position at Excellis Health?
Location: USA
Travel required: Yes
Excellis Health Solutions, LLC, an NNIT Group Company, is a global strategic management consulting services firm, based in New Hope, PA, England, Belgium and Denmark. An industry leader in supply chain, with a focus in Pharmaceuticals and Life Sciences and a specific niche in serialization, we offer a multitude of solutions using our comprehensive knowledge and proven turnkey solutions to clients. Excellis continues to expand its markets and services to meet the ever-changing industry needs. With 70 employees and historical growth of 25% plus year over year, Excellis anticipates continued growth in the United States and in Europe.
Job Summary
This Subject Matter Expert (SME) position will be responsible for providing expert guidance to clients in the areas of warehousing, pick/pack/ship and distribution operations within the pharmaceutical industry.
Areas of expected warehouse knowledge and experience include warehouse designs, operations, operating IT systems, pick/pack/ship processes, regulatory/licensing requirements and documentation/training considerations.
Areas of expected distribution knowledge and experience include distribution operations, operating IT systems, product serialization requirements, regulatory/licensing/Authorized Trading Partners (ATP) requirements and documentation/training considerations.
A thorough understanding of the current FDA/DSCSA regulations is also required to support the numerous pharmaceutical clients that utilize warehousing and distribution operations within the pharmaceutical supply chain.
An understanding of appropriate warehousing and distribution licensing and certification requirements is also highly desirable.
Role and Responsibilities
- Reviewing client warehousing, pick/pack/ship and distribution operations for compliance with FDA/DSCSA regulations
- Developing warehousing, pick/pack/ship and distribution strategies for each assigned client
- Assisting with the development of URS documents for any warehouse, pick/pack/ship or distribution software solutions
- Maintaining a comprehensive understanding of the associated regulations and licensing requirements
- Working with a project team to develop any required project documentation to support client deliverables
- Providing expertise in reviewing, revising and/or developing required SOPs to support current and future supply chain operations
- Assuring that identified resources are properly trained and supported during the implementation of any procedural or system changes
- Determining the requirements and statuses of ATPs within the pharmaceutical supply chain
Relationships
- Will work closely with other EHS project team members
- Will work closely with the client’s identified experts in the warehousing, pick/pack/ship and distribution operations
- Will work closely with the other client’s project team members, as required.
Qualifications and Education Requirements
- Prior warehouse, pick/pack/ship and/or distribution experience, preferably in a pharmaceutical environment
- Ability to read, understand and interpret regulations and licensing requirements as they pertain to warehousing and distribution operations (State licensing, NABP DDA accreditation, DSCSA regulations)
- Excellent verbal and written communication skills
- Previous project management experience or working on multidiscipline project teams
- BS/BA Degree
Preferred Skills
- Pharmaceutical warehousing, pick/pack/ship and/or distribution experience
- Experience with DSCSA regulations and pharmaceutical supply chain operations
- Experience with GS1 standards up to and including GS1 certification
- Self-starter with the ability to work independently
- Previous project management experience would be a plus
Benefits
Excellis Health Solutions offers a comprehensive benefits package including:
- Competitive Salary
- Medical, Dental, STD/LTD, Life and Vision Insurance offered
- 401K 50% match of first 5% contributed
- 8 Paid Holidays
- 12 days of annual Paid Time Off to start
Salary
Dependent upon Experience
*U.S. Citizens and those authorized to work in the U.S. are encouraged to apply. We are unable to sponsor at this time.
Valid Passport required