Sr. Director Technical Quality - ReqCode 12-9499

Overview:

Teva Parenteral Medicines is a global leader in the manufacture of generic injectable pharmaceuticals. A member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals. Teva Parenteral Medicines has an excellent opportunity for Sr. Director Technical Quality Operations.
Responsibilities:

The Senior Director of Technical Quality Operations will function as the primary liason between TPM's Quality organization and the departments within TPM that engage in any level of GxP operation. This includes, but is not limited to, Manufacturing, Quality Assurance, Quality Control, Regulatory Compliance, Engineering, Maintenance, Validation/Qualification, and Supply Chain.

A key focus of the Senior Director of Technical Quality Operations will be to provide technical quidance, direction and leadership on items that TPM has deemed critical from a compliance standpoint, including corporate compliance - corporate audits, all aspects of aseptic processing, such as: sterilization of process equipment, product sterility, equipment, systems, and methods validation, engineering, facilities, etc. It also will help lead in these areas during times of remediation and inspection, as needed.

The Senior Director of Techncial Quality Operations will work with his/her counterparts at other Teva sites and will participate in applicable industry forums to establish and implement Best Practices for TPM.

Provide technical review for Change Controls, CAPA's, deviations, investigations, etc.

Initiate and lead routine technical quality review sessions with site leads for GxP departments. As needed, involve other groups, such as Compliance or Training to support these sessions, ensuring industry and regulatory Best Practices are being implemented and/or met at TPM.

Inform the VP of Site Quality through regular written and verbal communications of compliance issues or areas of technical vulnerability at the site, particularly in re-start and product launches.

Function as Quality Subject Matter Expert (SME) for aseptic processing at the site.

Other duties as needed
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