Senior GCP Inspection Lead

4 weeks ago

London, Greater London, United Kingdom Lifelancer Full time
Job Title: Senior GCP Inspection Lead

Reporting to the Sr. Director, Global GCP Inspection Excellence, the Senior GCP Inspection Lead will be primarily responsible for GCP Health Authority inspection readiness for cross-functional clinical study teams, managing inspection logistics and process improvements to ensure research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices.

Key Responsibilities:
  • Supervise and manage activities related to inspection readiness, leading inspections conducted by regulatory health authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.
  • Collaborate with cross-functional clinical study teams to ensure a unified approach to inspection readiness strategy.
  • Manage Inspection Readiness Checklist, development of storyboards, identify and mitigate inspection risks, and facilitate/lead mock and actual inspections.
  • During inspections, assign inspection requests to appropriate subject matter experts (SMEs) and provide guidance to ensure timely fulfillment.
  • Create/revise appropriate SOPs and tools for inspection readiness and management.
  • Implement and maintain key QA systems, including investigations, Significant Quality Events (SQEs), Deviations, and CAPAs.
  • Demonstrate ability to solve complex problems requiring in-depth evaluation of various factors.
  • Fulfill all inspection commitments, respond to inspections, and carry out post-inspection activities, corrective and preventative actions, and resolve any issues for timely closure.
  • Manage a central repository of global inspection status and updates.
  • Meticulous attention to detail, excellent reviewing skills, and ability to independently manage multiple tasks in a fast-paced environment.
  • Support/manage pre-inspection visits at investigative sites.
  • Lead and manage lessons learned sessions after inspections, identifying trends and best practices to implement process improvements.
  • Proven ability to set strategies for and drive initiatives aimed at improving quality processes.
  • Strong leadership skills and ability to mentor others.
  • Thorough understanding of international regulations applicable to the conduct of clinical trial operations on a global scale.
Qualifications:
  • BA/BS degree required
  • Expert knowledge of relevant FDA, EU, ICH GCP guidelines
  • Minimum of 7 years of experience in GCP-related Quality Assurance function of the pharmaceutical, biotechnology or related health care industry.
  • High level of understanding of international GCP requirements and standards in the pharmaceutical, medical device and biotech industries.
  • Excellent English language skills, and additional language depending on locations and need.
  • Excellent verbal and written communication skills
  • Ability to effectively collaborate in a dynamic environment.

  • Senior GCP Inspection Lead

    1 month ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job Title: Senior GCP Inspection LeadReporting to the Sr. Director, Global GCP Inspection Excellence, the Senior GCP Inspection Lead will be primarily responsible for GCP Health Authority inspection readiness for cross-functional clinical study teams, managing inspection logistics and process improvements to ensure research and development activities are...

  • Senior GCP Inspection Lead

    1 month ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job Title: Senior GCP Inspection LeadReporting to the Sr. Director, Global GCP Inspection Excellence, the Senior GCP Inspection Lead will be primarily responsible for GCP Health Authority inspection readiness for cross-functional clinical study teams, managing inspection logistics and process improvements to ensure research and development activities are...

  • Global GCP Inspection Lead

    4 weeks ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job Title: Associate Director, Global GCPWe are seeking an experienced professional to lead our GCP inspection readiness efforts across various clinical study teams. The successful candidate will be responsible for managing inspection logistics and process improvements to ensure RD activities are compliant with regulatory requirements, guidelines, laws, and...

  • Global GCP Inspection Lead

    4 weeks ago

    London, Greater London, United Kingdom Lifelancer Full time

    Job Title: Associate Director, Global GCPWe are seeking an experienced professional to lead our GCP inspection readiness efforts across various clinical study teams. The successful candidate will be responsible for managing inspection logistics and process improvements to ensure RD activities are compliant with regulatory requirements, guidelines, laws, and...

  • GCP DevOps Engineer

    2 months ago

    London, Greater London, United Kingdom Extended Family Senior Services Llc Full time

    Job Title: GCP DevOps EngineerWe are seeking a highly skilled Google Cloud DevOps Engineer to join our team at Extended Family Senior Services Llc. The ideal candidate will have a proven track record in driving transformation and migration projects on the Google Cloud Platform.Key Responsibilities:Collaborate with cross-functional teams to design, implement,...

  • GCP DevOps Engineer

    2 months ago

    London, Greater London, United Kingdom Extended Family Senior Services Llc Full time

    Job Title: GCP DevOps EngineerWe are seeking a highly skilled Google Cloud DevOps Engineer to join our team at Extended Family Senior Services Llc. The ideal candidate will have a proven track record in driving transformation and migration projects on the Google Cloud Platform.Key Responsibilities:Collaborate with cross-functional teams to design, implement,...

  • GCP Cloud Architect

    2 weeks ago

    London, Greater London, United Kingdom TEKsystems Full time

    About the RoleWe are seeking a highly skilled GCP Cloud Architect to join our team at TEKsystems. As a key member of our GCP Platform team, you will be responsible for designing, building, and delivering cloud solutions that meet the evolving needs of our clients.Key ResponsibilitiesDevelop and implement GCP cloud modernization strategies for customer...

  • Senior Director, Quality Assurance

    3 weeks ago

    London, Greater London, United Kingdom Clinical Professionals Limited Full time

    Job Title: Senior Director, Quality AssuranceJob Summary:We are seeking an experienced Senior Director, Quality Assurance to lead our GCP inspection readiness efforts. The successful candidate will be responsible for managing inspection logistics, process improvements, and ensuring compliance with regulatory requirements.Key Responsibilities:Supervising and...

  • Senior Quality Assurance Manager

    3 weeks ago

    London, Greater London, United Kingdom Mactech Inspection Limited Full time

    About the Role:Mactech Inspection Limited is seeking a highly skilled Quality Management Lead to join our team at Sizewell C, a pioneering megaproject in the UK.As a key member of our team, you will be responsible for ensuring the highest standards of quality in our operations, driving continuous improvement, and collaborating with cross-functional teams to...

  • Senior Technical Lead

    3 weeks ago

    London, Greater London, United Kingdom Harnham Full time £80,000 - £90,000

    Job Description: We are partnering with a computer vision vendor who solves problems for the FMCG space. They were founded roughly 5 years ago and are a computer vision start-up that operates in the retail and manufacturing space. They are currently planning their series A at the end of this year and are on track to expand the business from 40 to over double...

  • GCP Security Detection Engineer Position

    3 weeks ago

    London, Greater London, United Kingdom Maclean Moore Ltd Full time

    Job Title: GCP Security Detection EngineerJob Summary:We are seeking a skilled GCP Security Detection Engineer to join our team at Maclean Moore Ltd. As a key member of our security team, you will be responsible for designing, implementing, and managing security detection use cases using GCP Chronicle and Splunk. Your expertise will help us to continuously...

  • GCP DevOps/Systems Engineer

    2 weeks ago

    London, Greater London, United Kingdom EPAM Systems Full time

    EPAM Systems is seeking an experienced Lead GCP DevOps/Systems Engineer to join our dynamic team in London.We are looking for a highly skilled professional who is passionate about leveraging advanced cloud technologies to propel our financial services clients to new heights.In this prominent role, you will be vital in directing and executing sophisticated...

  • Senior Java Technology Lead

    2 weeks ago

    London, Greater London, United Kingdom Opus Recruitment Solutions Ltd Full time

    Senior Java Developer OpportunityOpus Recruitment Solutions Ltd is currently seeking a skilled Senior Java Developer to lead the integration of legacy Java applications into a new Oracle HCM System.This is a remote, UK-based role that offers a competitive daily rate of £600, Inside IR35.You will be responsible for spearheading the technical roadmap of the...

  • Senior Software Development Lead

    1 month ago

    London, Greater London, United Kingdom Spectrum IT Recruitment Full time £120,000

    Senior Software EngineerJoin Spectrum IT Recruitment, a leading technology firm, as we seek a highly skilled Senior Software Engineer to lead our team in delivering innovative solutions for our clients.About the Role:Lead the development and deployment of our marketplace solutions, providing hands-on support and consulting on design and architecture...

  • Senior Software Development Lead

    1 month ago

    London, Greater London, United Kingdom Spectrum IT Recruitment Full time £120,000

    Senior Software EngineerJoin Spectrum IT Recruitment, a leading technology firm, as we seek a highly skilled Senior Software Engineer to lead our team in delivering innovative solutions for our clients.About the Role:Lead the development and deployment of our marketplace solutions, providing hands-on support and consulting on design and architecture...

  • Senior Inspection Engineer

    2 weeks ago

    London, Greater London, United Kingdom TSS UK Ltd Full time

    We are seeking a highly skilled Senior Inspection Engineer to join our team at TSS UK Ltd.The successful candidate will be responsible for ensuring compliance with LOLER regulations, logging and maintaining accurate paperwork, and possessing a strong understanding of NVQ Level 3 and wire rope examination.Key Responsibilities:Conduct thorough inspections of...

  • Senior Quality Assurance Team Lead

    2 weeks ago

    London, Greater London, United Kingdom GSK Full time

    Job PurposeThis position is responsible for leading a team of Quality Business Partners who deliver independent quality expert support to stakeholders. The incumbent is a member of the QBP Therapeutic Area Leadership Team and provides input into the quality strategy of this function. The position is responsible for ensuring that quality is designed into...

  • Senior Product Inspection Engineer

    4 weeks ago

    London, Greater London, United Kingdom https:www.energyjobline.comsitemap Full time

    Product Inspection ExpertiseThe Product Inspection function plays a crucial role in ensuring the quality and performance of products. As a key member of our team, you will be responsible for conducting detailed inspections and measurements of products, collaborating with engineering teams to resolve product issues, and developing and implementing inspection...

  • Senior Data Science Lead

    2 weeks ago

    London, Greater London, United Kingdom Sanderson Full time

    Senior Machine Learning EngineerDrive innovation with cutting-edge ML/AI technologies as a Senior Machine Learning Engineer at Sanderson's Data Science team. Develop and deploy algorithms, tackle complex data challenges, and support commercial objectives.Key Responsibilities:Lead Algorithm Development: Design and implement machine learning models to drive...

  • Senior Director, Quality Assurance

    4 weeks ago

    London, Greater London, United Kingdom Clinical Professionals Limited Full time

    Job Title: Associate Director, Client ManagementWe are seeking an experienced Associate Director to join our team at Clinical Professionals Limited. As a key member of our Client Management department, you will be responsible for ensuring the highest level of quality and compliance in our client-facing activities.Key Responsibilities:Lead and manage...