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WD140228 - Quality Innovation Lead, Digitial & Devices

Job Details

  • Permanent, Full Time
  • Greater London
  • Closes 8th November 2017
  • Requisition ID: WD140228
  • Required degrees: Bachelors
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Basic qualifications:

Bachelor’s Degree in Chemistry, Pharmacy, or other closely related area

Experience in the Consumer Healthcare and Medical Device industry

International experience and expert knowledge in Medical Devices, Software as Medical Device Products, Wearable Devices which communicate to Software applications and the Quality requirements which govern these products

Experience as a Quality or IT Quality professional working in the Pharmaceutical, Consumer Healthcare or Medical Device industry

Additional cross-functional Quality experience in:
o Manufacturing Quality
o Quality Assurance
o Quality Auditing
o Ability to identify and reduce compliance risk
o Proven delivery of Quality strategies that resulted in robust product launches

Ability to lead within a matrix organization, integrating complex multifunctional efforts crossing multiple business areas at an above country, global level

Experience in leading compliance initiatives in complex regulatory environments

Experience in managing without authority a broad, diverse team

Preferred qualifications:
Master’s Degree or Higher

Expert in stakeholder management, influencing, setting direction, and collaborating at the leadership level

Excellent presentation and communication skills

Details:
GlaxoSmithKline has an opening for a Quality Innovation Lead, Digital & Devices. Reporting to the Global Quality Strategy, Governance & Categories Lead, in this role you will provide the GSK Consumer Healthcare organization expertise and guidance in the digital and device space. You will deliver the Quality Strategy which will support the innovation pipeline as it pertains to digital and device software and products (Medical Devices, Software as Medical Device Products, Wearable Medical Devices which communicate to Software, Software Applications which communicate to Wellness or Medical Device/Combo units) ensuring these comply with regulatory requirements, local market regulations, and industry standards.

In this role, you will build a network of collaborative relationships across functional teams within the Commercial Categories, Regulatory, R&D, Countries, and Manufacturing Units. You will design and implement a compelling vision for the team and deliver against the Consumer Healthcare Quality Unit’s strategy and mission, ensuring all regulatory and quality requirements are met for both innovation and existing products per GSK Values and company requirements.

You will be a Quality pioneer in which you will be relied upon as a subject matter expert which can guide and provide expertise to enhance competency and capability of the applicable Quality unit teams and GSK Consumer Healthcare. Work collaboratively and seamlessly with other Quality groups within the organization, facilitating rapid issue resolution. Responsible for identifying, communicating and proactively mitigating Quality risks throughout the product lifecycle, and draw from expertise and key learnings which contribute to a strong Quality culture & mindset within the Category and Commercial teams. Responsible for operational activities which include, but are not limited to GSK policy and standard writing, lead/participate in device design committees and design controls, performing Due Diligence visits, etc.

Key Responsibilities include the following:
• Provide Quality decisions at Category Governance forums including bringing key Quality and compliance initiatives, determining strategy, and ensuring crisp execution and delivery of key compliance objectives. Provides Quality advice across the Categories and cross functional teams which have a direct/significant impact on the company portfolio; specifically, on all aspects of drug/devices/digital platforms development and regulatory requirements, both current and future.
• Provide Quality decisions at Category Governance forums including bringing key Quality and compliance initiatives, determining strategy, and ensuring crisp execution and delivery of key compliance objectives. Provides Quality advice across the Categories and cross functional teams which have a direct/significant impact on the company portfolio; specifically, on all aspects of drug/devices/digital platforms development and regulatory requirements, both current and future.
• Performs Scope & Seek and initial Due Diligence activities for device related innovation e.g. Medical devices including electronics/apps, unregulated digital devices, In Vitro Diagnostic devices, Combination products. Perform assessments of products and processes to identify key quality and compliance risks and develop a risk mitigation strategy to remediate issues.
• Leads & directs Quality activities for new device & digital initiatives i.e. IVDS, Electronics/Apps, combination products, providing oversight and interaction with category, aligned Quality Leads and functional areas, and ensures requirements for design review committees and designed processes are met ahead of commercialization.
• Develops and aligns the Quality strategic vision for device and digital innovations; interact with Commercial Category as ‘one voice of Quality’ representing the CH Quality Unit and ensuring the end to end oversight of the product development meets Consumer Healthcare’s Quality requirements and expectations.
• Provides routine management updates to the Consumer Healthcare Quality Leadership Team to ensure risks are identified and mitigated and that the proper Quality support is allocated to deliver the innovation pipeline
• Ensure appropriate prioritization and resourcing of projects and delivery of high quality support to agreed timelines to meet launch commitments on time in full
• Leads non-product related activities, both in the function and cross functionally, to direct new policy or pioneer new processes or improvements to GSK's competitive advantage.
• Influence the external regulatory environment through networking with key individuals, identifying opportunities and influencing guidelines. May act as GSK Quality representative to external groups for specific topics
• In conjunction with CH Quality Unit, ensures support for the full life cycle of products, including: maintenance activities; design to value, complexity reduction, value engineering initiatives, change management, etc. with direct partnership with regulatory, R&D, supply chain and technical excellence.
• Oversees compliance in all actions by ensuring global, regional and local processes, policies, SOPs and working instructions adherence.


*LI-GSK

Contact information:
You may apply for this position online by selecting the Apply now button.

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