Global Device Lead for MSAT & Tech Transfer

SHPE Houston; Waltham (MA); Hybrid; USD 143,000 - 238,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive program

Health care benefits

Retirement benefits

Paid holidays and vacation

Parental leave

Job summary

GSK is seeking a Device Lead for Global MSAT Drug Delivery and Aseptic Technology to be the technical owner of the Device platform, accountable for device delivery to manufacturing sites globally. The role requires flexibility for international travel and close collaboration with R&D, Quality, and Supply Chain functions.

Responsibilities include leading cross-functional teams, managing risk, and driving innovations in device technologies and manufacturing processes to improve quality and reduce

Qualifications

• Bachelor's degree in Engineering or Science or equivalent.
• 10+ years' experience in Medical Device Manufacturing environment or
• Master's with 5+ years experience in Medical Device Manufacturing.

Responsibilities

• Be the SPOC technical SME interface between Device/Component suppliers and GSK MSAT site teams.
• Deliver a robust supply strategy of Device platform by collaborating with Strategy, Procurement, Quality, Logistics etc.
• Lifecycle manage the Device Platform including Technology Transfer from R&D and post-approval regulatory changes.
• Ensure global device/component manufacturing processes are capable, efficient and meet specification.
• Own and maintain device design including regulatory DHF/Technical file requirements to ensure global standardization.
• Support Device Director on Continuous Improvement and Business projects within GSC.
• Cross-functional communication of technical global device challenges and successes.

Skills

CMC Strategy

Data-Driven Decision Making

Data Integrity

Debate Moderation

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Process Optimization

Project Leadership

Risk Awareness

Scientific Writing

Technology Transfer

Education

Bachelor's degree in Engineering or Science

Master's Degree with 5+ years of Medical Device Manufacturing experience

Regulatory GMP/ISO knowledge in medical devices

Job description

GSK is seeking a Device Lead for Global MSAT Drug Delivery and Aseptic Technology to be the technical owner of the Device platform, accountable for device delivery to manufacturing sites globally. The role requires flexibility for international travel and close collaboration with R&D, Quality, and Supply Chain functions.

Responsibilities include leading cross-functional teams, managing risk, and driving innovations in device technologies and manufacturing processes to improve quality and reduce