Global Device Lead: Tech Transfer & Manufacturing

GlaxoSmithKline; Zebulon (NC); Hybrid; USD 143,000 - 238,000; Full time

Job summary

GlaxoSmithKline in the United States is seeking a Device Lead for Global MSAT Drug Delivery and Aseptic Technology to own the Device platform and be globally accountable for device delivery to GSK Manufacturing sites, with potential international travel.

The role is hybrid, on-site part of the week, and requires coordination across Strategy, Procurement, Quality, Logistics, and Regulatory functions to drive improvements and cost efficiencies in drug delivery devices.

Qualifications

• Bachelor's in engineering or a Science Degree; 10+ years in Medical Device Manufacturing.
• Or Master's degree with 5+ years in Medical Device Manufacturing.
• Experience working in GMP/regulatory environment and ISO standards (DHF, MDR, FDA QSR, ISO 13485).

Responsibilities

• Be the SPOC technical SME interface between Device suppliers and GSK MSAT site teams for improvement projects and risk management.
• Deliver a robust supply strategy of the Device platform in collaboration with Strategy, Procurement, Quality, and Logistics.
• Lifecycle manage the Device Platform, driving Technology Transfer from R&D and maintaining lifecycle post-approval.
• Ensure global device manufacturing processes are capable, efficient and meet specifications.
• Own and maintain Device design and regulatory files to standardize global supply and ensure compliance.

Skills

SPOC interface

Regulatory knowledge

Risk management

Technology Transfer

GMP knowledge

Device design

Education

Bachelor's in engineering or science

Master's degree in engineering

Job description

GlaxoSmithKline in the United States is seeking a Device Lead for Global MSAT Drug Delivery and Aseptic Technology to own the Device platform and be globally accountable for device delivery to GSK Manufacturing sites, with potential international travel.

The role is hybrid, on-site part of the week, and requires coordination across Strategy, Procurement, Quality, Logistics, and Regulatory functions to drive improvements and cost efficiencies in drug delivery devices.