Head, Medical Device Technologies

Job content

Site Name: Field Worker - CHN

Posted Date: Mar 16 2022

The Global Manufacturing Science and Technology (MSAT) organization is a network-focused function which provides strategic direction and technical and operational support to ensure that GSK Pharma Supply Chain (PSC) network and site goals and objectives are achieved, and determined strategy executed. MSAT is the keeper of the body of manufacturing process knowledge, creates the instruction set and ensures manufacturing operations stay aligned with the registered process. MSAT’s primary functions are to lead technology transfers, implement control strategies, provide technical process support, provide process support across the product lifecycle, while implementing new products and new modalities for commercial products and product-related programs within the GSK PSC perimeter.

What We Are Looking For

A high caliber, seasoned industry expert in Medical Devices, or Drug-Device Combination Products, to support our rich portfolio of parenteral products. A true leader who will influence internally and externally, using strong communication skills to build partnerships at all levels of the business. You will need strong people and project leadership skills and must be comfortable working globally.

The candidate should have established track record of developing and commercializing medical devices such as autoinjectors for parenteral products. An in-depth understanding is essential in drug-device combination products development, device design controls, risk management and Medical Device regulations. As the Medical Device Technology Head, you will be responsible for device onboarding strategies across the whole GSK PSC product portfolio, delivering continuous improvement and lifecycle management of parenteral devices. You’ll define these standards, ensuring capability across the business and our external supply partners through collaboration across PSC and R&D, covering both biopharma and small molecules.

Key Responsibilities Include, But Are Not Limited To

• Platform ownership of GSK commercial products and device platforms.
• Management of external supply and project-specific change controls to ensure process capability and EPR’s of commercial products.
• Commercial site-to-site transfers and capacity upgrades.
• Drive resolution of deviations and investigations for commercial products.
• Represent commercial and manufacturing network perspective on device development working teams during the technology selection, design, development, characterization, and commercialization of medical devices.
• Drive technical teams by leveraging skill across network in solving complex problems using engineering modelling and simulation tools, design and prototyping tools, statistical analysis, benchtop experiments and analysis, design for manufacturability/assembly techniques and design for Six Sigma.
• Ensuring effective and efficient, fit for purpose capability and processes are in place to support the industrialization of new platforms, continuous improvement of our existing platforms, adoption of new technologies and platform lifecycle management in conjunction with our 3rd party supply base partners.
• Demonstrate a working understanding of regulatory, risk management, new technologies/trends, and design control related fields (21 CFR Part 820, ISO13485, ISO14971, and other relevant global standards).
• Providing regulatory filing support (IND, BLA, MAA, etc.) for lifecycle management and building retrospective technical files for legacy combination products and other medical devices across the GSK portfolio.
• Working with Global and Regional / Local Regulatory to understand, translate and apply appropriate regulations, being conversant with statutory obligations and GSK procedures for all regulatory requirements in devices.
• Ensure GSK corporate governance is upheld.
• Serve as a primary point of contact representing the organization with external agencies, partners, and vendors.
• Identify, recruit, and retain talent to accomplish project and departmental objectives within agreed timelines, planning, maintaining, and managing departmental budgets, participate in capital planning and capital project execution.
• Maintaining an active technical talent management and succession program for your team.
• Leading and supporting the modernization of strategic innovation programs and franchise priority projects, working seamlessly with R&D and PSC organizations.
• Partnering with R&D to define first intent platforms that support acceleration and intensification across the portfolio of parenteral devices.
• Travel 10%
  

Basic Qualifications

• Bachelor’s degree in Engineering or science related field
• 15+ years of experience in medical device, especially in parenteral combination products and autoinjector design, development, and operations technical roles
• 8+ years of experience in leading/managing multifaceted organizations
  

Preferred Qualifications

• Advanced degree, MS or PhD
• Knowledge of multiple drug product dosage forms, and multiple devices
• Conversant with GMP, Medical device US/EU/ROW Regulations
• Track record of success in a management or leadership role
  

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

• Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.
• LTI-GSK
  

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