Associate Director / Device Lead

The Device Lead of Global MSAT Drug Delivery and Aseptic Technology will serve as the technical owner of the Device platform and be globally accountable for Device delivery into GSK Manufacturing sites from the Supply Base. The role requires flexibility, adaptability, and international travel where applicable.

Responsibilities

• Act as the SPOC technical SME interface between Device/Component suppliers and GSK MSAT site teams, providing device-related technical management for business improvement projects and risk management activities, and representing MSAT at supplier technical and project meetings.
• Deliver a robust supply strategy for the Device platform, collaborating with GSK functions (Strategy, Procurement, Quality, Logistics) to drive delivery of mould tool & assembly asset validation programmers.
• Lifecycle manage the Device Platform, driving technology transfer from R&D, maintaining throughout the platform life, including post-approval regulatory change management, continued process verification, and manufacturing efficiency improvements.
• Ensure global device/component manufacturing processes are capable, efficient, and meet specifications.
• Maintain Device design and regulatory documentation (DHF/Technical file) to meet global standards, relevant external standards and internal procedures (e.g., FDA 21 CFR 820, EU 2017/745, MDR, ISO 13485, ISO 14971, ISO 10993).
• Support Device Director, Device Strategy and Device Procurement on continuous improvement and business projects within the Global Supply Chain (GSC).
• Communicate technical global device challenges and successes cross-functionally, influencing R&D and supply chain teams to ensure technical and commercial success of drug delivery devices and integral combination products.
• Drive innovation through new device technologies and ways of working, championing business cases for sustainable manufacturing technology implementation or strategic projects (quality by design, design for manufacturing, product/process understanding, design control, digital data management, analytical competency).
• Perform risk management activities (e.g., risk file review/approval) and lead the risk management process as risk owner when required.

Basic Qualifications

• Bachelor's degree in engineering or a science discipline (Process/Mechanical Engineering, Materials Science, Biomedical Engineering/Chemistry).
• 10+ years’ experience in Medical Device/pharmaceutical manufacturing environment. OR Master’s degree with 5+ years of experience in Medical Device/pharmaceutical manufacturing environment.
• Experience in a pharmaceutical and/or medical device GMP regulatory environment, relevant ISO standards, and specific legislation (e.g., DHF, MDR, FDA Medical Device guidance).

Preferred Qualifications

• Knowledge of pharmaceutical development activities and R&D processes for product development, NPS and technology transfer.
• Strong understanding of device assembly, metrology, plastics testing techniques & procedures, and GSK Specification & Drawing systems.
• Experience leading device groups in a global matrix environment with successful global asset lifecycle management.
• Ability to operate independently and collaborate with multiple stakeholders across global business units.
• Strong interpersonal, leadership, verbal and written communication skills.
• Excellent judgment, prioritization, and decision-making abilities with a proven track record.
• Basic understanding of data science, digital data infrastructure, visualization, and statistical analysis.
• Knowledge of GMP, ICH Guidelines, FDA QSR, and EU MDR device requirements, and familiarity with regulatory registration processes (FDA, EMA, MHRA).
• Specialization in regulations and ISO standards relevant to medical devices and combination products.
• Knowledge of injection mould tooling design & processing, device polymers and materials engineering, springs/wire forming, device testing and lab management, mathematical modeling, device automated assembly techniques.

If based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary ranges from $142,725 to $237,875.

Benefits

• Annual bonus, eligibility for share-based long-term incentive program, and comprehensive benefits including health care and other insurance (for employee and family), retirement benefits, paid holidays, vacation, paid caregiver/parental and medical leave.

GSK is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.