|
Reference Number:
TPOMgr-EHNJ
Job Description:
Our major pharmaceutical client is looking for Third Party Operations (TPO) Manager for a East Hanover, NJ.
- Optimize package designs, and manage contracted activities to assure delivery of on time, quality clinical finished goods (Ph I-IV) packaged according to GMP, through effec-tive supplier relationship and performance management. These activities are performed with DSM approved contractors, in cooperation with Quality Assurance and other line functions. 1. Primary liaison with contractors for external packaging and distribution campaigns
2. Manages all finance activities, including Request for Proposal (RFP) for bidding & vendor selection, Grants, Purchase Orders (PO) and invoice approval
3. Manage all packaging activities, including Work Order (WO) creation, review & ap-proval of contractor packaging records and monitoring in-process / on-going work at contractors with limited supervision
4. Packaging design optimization; works with SP&D to advise on and challenge protocol aspects related to average packaging design
5. Initiates audits and participates in audits together with GMP QA and GCP QA (where applicable) to assess contractor capabilities
6. Organizes and coordinates the shipment of drug product and packaging material to contractors
7. Responsible for materials and inventory management of all drug product, compo-nents and labels at the contractors.
8. Establishes and manages supply related timelines with other groups as SP&D, QA, PHAD, to ensure agreed timelines are met
9. Authorizes destruction of outdated material
10. Contribute to/lead process improvement activities within Global DSM and TPO
11. Establishes contact network with Novartis approved contractors and vendors
Requirements:
- BS degree required, masters preferred
. At least 2 years of relevant experience in Pharma-ceutical Development, Clinical Development, Clinical Supply Operations, Project Management or Related Field.
2. Intermediate organization, planning and leadership skills.
3. Intermediate communication, negotiation and in-terpersonal skills.
4. Ability to strategically plan, organize and manage multiple projects simultaneously.
5. Demonstrates track record of creativity and prob-lem solving in projects.
6. Demonstrates working knowledge of clinical supply systems and specialized tools.
7. Intermediate knowledge of development activities and processes.
8. Intermediate project management skills.
9. Intermediate presentation skills.
10. Ability to work in interdisciplinary teams.
11. Knowledge of relevant GxPs and company policies as well as applicable multinational regulations.
Qualified candidates should please send a MS Word copy of their resume to manisha@sunrisesys.com. PLEASE INCLUDE THE JOB REF # "TPOMgr-EHNJ" IN THE SUBJECT LINE!
Experience Level:
Unspecified
Requirements:
|
