Quality Assurance

New York  ‐ Onsite
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Description

Summary
  • This position is responsible for supporting the Compliance Head in managing the implementation of Policies and Standard Operating Procedures (SOPs) to ensure compliance with regulatory requirements, maintain/improve quality, and ensure inspection readiness related to the conduct of clinical studies and the management of clinical data for the global Vaccine Clinical Research (VCR) organization.
  • This includes Phase 0 through Phase 4 studies [post-marketing commitments and licensing studies.
  • The purpose of this position is to ensure a culture and maintain processes to drive high standards of excellence, quality, and compliance by:
    Coordinating the review of Policies and SOPs by providing review and impacts to VCR processes and requesting SMEs input
    Developing Vaccines Clinical specific guidance documents to support SOP processes
    Developing and implementing appropriate SOP training curricula and ensuring training compliance
    Managing the preparation and support for inspections
    Managing the tracking, preparation for and responses to internal audits
    Responsible for timely follow up of audit responses.
    Assessing, managing, and tracking area of compliance risks
    Liaising with appropriate departments, functions and SMEs regarding compliance related programs, questions, and communications
    Develops and manages plans to achieve VCR compliance objectives.
  • SOPs/Processes:
    Provide project management expertise to successfully develop and implement global plans for VCR that ensure compliance with quality processes,
    procedural documentation, as required.
    Identify and track gaps/compliance risk regarding colleague understanding and develop plan to address them.
    Develop implementation guidelines, task ownership matrices and process maps as necessary for implementation of SOPs.
    Identify and maintain Subject Matter Experts (SMEs) to assist in the development/revision and implementation of Standard Operating Procedures (SOPs) and/or Implementation Guidelines as they relate to Vaccine Clinical Research.
    Plan/manage projects related development and implementation of VCR quality processes and procedural documentation.
  • Training Compliance Oversight:
    Coordinate curriculum management and proactively identify roles within Vaccine Clinical that are impacted by changes to ensure colleagues and contractors are assigned the appropriate training including new hire training. Identify unmet training needs and areas of opportunities.
    Track training compliance through regular reporting and follow-up. Monitor metrics and provide reports to management regarding training completion. Work with Operational Performance Strategies and other training resources to define needs and implement required training.
    Inspection Support:
    Manage inspection readiness activities: Coordination, communication, documentation, and training.
    Develop, implement, and maintain compliance and inspection readiness plans in collaboration with key partners.
    Ensure required documents are inspection ready.
    Quality/Audit Management:
    Interface with Quality Assurance/Corporate Compliance and responsible functional areas, investigational sites, labs, and vendors regarding corporate, quality and process audits. Provide progress updates, including summarization of key audit findings and audit resolution, to leadership.
    Responsible for coordinating responses to deficiencies found on audits by identifying root causes of the deficiencies, developing and implementing corrective actions, and participating in modifications to SOPs to prevent recurrence of deviations and/or deficiencies found on an audit.
    Identify of areas of risk in quality, compliance and inspection readiness. Develop plans to address risk with management. Analyze trends and assist in development and implementation of preventative action and risk mitigation strategies within Vaccines Clinical.
Qualifications
  • The candidate will have comprehensive knowledge of GCP principles and concepts and work with the supervisor and Vaccines management to identify gaps and areas of opportunity to support colleague ability to accurately and consistently apply principles, procedures, and processes to ensure patient safety and good clinical practice.
  • Bachelor of Arts/Bachelor of Science degree with 8+ years in pharmaceutical, regulatory, quality assurance or health care fields
  • Master of Art/Master of Science degree with 5+ years in pharmaceutical, regulatory, quality assurance or health care fields
  • Proven experience in a compliance position required.
  • Strong knowledge of and experience with ICH, FDA, EMEA and GLP/GCP/GMPs, clinical processes
  • Project/process management
  • Facilitation management, Training design and development
  • Computer and systems skills: industry enterprise systems
  • MS Office applications and a solid understanding and use of relational databases
  • Strong communication (written and verbal), facilitation and presentation skills
  • Some working knowledge of setting up and monitoring/QA or routine GMP processes preferred
Start date
n.a
From
Synectics
Published at
02.04.2016
Project ID:
1102481
Contract type
Freelance
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