Associate Director, Device Lead

This role is the technical owner of the Device platform and is globally accountable for Device delivery into GSK Manufacturing sites from the Supply Base. The position requires flexibility and adaptability to meet the resource needs of the business, including international travel where applicable.

Responsibilities

• Serve as the single point of contact (SPOC) and technical subject matter expert (SME) interface between Device/Component suppliers and GSK MSAT site teams, providing device-related technical management for business improvement projects and risk management activities. Represent MSAT at supplier technical and project meetings.
• Deliver a robust supply strategy for the Device platform by collaborating with other GSK functions such as Strategy, Procurement, Quality, and Logistics, including the delivery of mold tool and assembly asset validation programs.
• Lifecycle manage the Device Platform, driving Technology Transfer from R&D and maintaining it throughout the platform’s life—including post-approval regulatory change management, continued process verification, and increasing manufacturing efficiencies while reducing COGs.
• Ensure global device/component manufacturing processes are capable, efficient, and meet specifications.
• Own and maintain the Device design, including regulatory DHF/Technical file requirements, to ensure global standardization of Device supply. Maintain an overview of relevant external standards and compliance with internal procedures for device manufacture, supply, and risk (e.g., FDA 21 CFR 820, (EU) 2017/745, Medical Device Regulation (MDR), ISO 13485, ISO 14971, and ISO 10993).
• Support the Device Director, Device Strategy, and Device Procurement organizations on Continuous Improvement and Business projects within the Global Supply Chain (GSC) to deliver MSAT objectives.
• Work cross-functionally to communicate technical global device challenges and successes, influencing at all levels—including R&D and supply chain teams—to ensure both technical and commercial success of drug delivery devices and integral combination products for GSK.
• Drive innovation through the introduction of new and novel device technologies and/or ways of working. Champion business cases for sustainable manufacturing technology implementation or other strategic projects, including those related to quality by design, design for manufacturing, product and process understanding, design control, digital data management, and analytical competency.
• Perform risk management activities (e.g., risk file review/approval) when working with product and project teams. Lead the risk management process as the ‘risk owner’ when required.

Requirements

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

Preferred Qualifications

• Knowledge of pharmaceutical development activities and processes adopted by R&D relating to product development, NPS, and Technology Transfer.
• Good understanding of device assembly, metrology, plastics testing techniques and procedures, and GSK Specification & Drawing systems.
• Experience leading device groups in a global matrix environment with a track record of successful global asset lifecycle management.
• Ability to operate independently within a sphere of influence and work with multiple stakeholders across global business units, both internally and externally.
• Strong interpersonal and leadership skills; committed team player prepared to work in and embrace a team-based culture.
• Ability to interact well with peers, subordinates, and senior personnel in scientific, quality, engineering, and operational disciplines.
• Strong verbal and written communication skills.
• Excellent judgment, prioritization, and decision-making skills; effective at implementing decisions and proven track record.
• Working understanding of data science, including digital data infrastructure, visualization, and statistical analysis.
• Knowledge of current GMPs, ICH Guidelines, FDA QSR, and EU MDR device requirements, and familiarity with regulatory registration processes by FDA, EMA, and MHRA.
• Specialization in regulations and ISO standards, medical device requirements, and global device and combination product regulations (e.g., 21 CFR 820, EU MDR 2017/745, ISO 13485, and ISO 14971).
• Knowledge of Injection Mold Tooling Design & Processing, Device Polymers and Materials Engineering, Springs/Wire Forming, Device Testing and Lab Management, Mathematic Modelling, and Device automated assembly techniques.

Work Arrangement

This role is offered as a hybrid position with an expectation to be on-site part of the week. The role may require occasional travel to suppliers or other GSK sites.

Pay

If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges from $142,725 to $237,875. The US salary ranges take into account work location, candidate skills, experience, education level, and market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share-based long-term incentive program, dependent on the level of the role.

Benefits

• Health care and other insurance benefits (for employee and family).
• Retirement benefits.
• Paid holidays, vacation, and paid caregiver/parental and medical leave.

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