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Director/Senior Director, Head of Global Quality Management System

Jobleads.com
Job LocationNottingham
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Company OverviewQuotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we helpbiotech and pharmacustomers save precious time and money in getting drugs to patients.As a growing and successful business, we employ more than 1,300talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development communitythat’s focused oninnovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures,fast. Because humanity needs solutions, fast.The RoleWe have an exciting career opportunity for a Director/Senior Director, Head of Global Quality Management System based at our site in Nottingham.Reporting to the Senior Vice President, Global Quality and Regulatory, the Director, Global Quality Management System will be responsible for the establishment of the strategic direction and continued harmonization of the company’s Quality Management System(QMS) and applications in support of our phase appropriate design lifecycle management.This role will assure the continued compliance of the company’s QMS with applicable global regulations and standards, and monitor metrics to routinely assess the compliance profile at each site. Additionally, this role will drive continuous improvement programsto advance GxP execution and the quality culture across Quotient Sciences network.This position will manage the following core functions:

  • Global Supplier/Vendor Audits and Qualification – auditor qualification
  • Global Systems Compliance in partnership with IT
  • Validation (vertically integrated with site-based teams)
  • CSV/ Data Integrity (vertically integrated with site-based teams)
  • eQMS/eDMS (Veeva) (vertically integrated with site-based teams)
Main tasks and responsibilities
  • Establish strategic direction, harmonization, life-cycle management and continuous improvement of Policies, Standard Operating Procedures, Work Instructions, Templates, and other required documents to assure continued efficient, effective and compliantquality management system that supports the company’s business.
  • Collaborate with site Quality and Regulatory Affairs team across the organization and other key stakeholders to identify local quality processes that can be harmonized across all sites while integrating industry best-practices.
  • Maintain up to date knowledge of GxP regulations, guidelines and expectations of regulatory agencies around the world for markets in which we operate or plan to operate. Monitor global regulations and standards for changes that impact the Quotient QMS.
  • Communicate changes to site Quality and Regulatory Affairs team and proactively work to assure global policies and procedures remain compliant.
  • Effectively communicate across the business to keep all functions informed on new or changing quality system requirements affecting their area. Influence others to ensure compliance with company policies and procedures through positive interactions andgain alignment and support for improvement activities.
  • Oversee the implementation and maintenance of the company’s global Quality applications (e.g. electronic document management system, electronic quality management system) to assure consistent practices across all sites. Identify opportunities to maximizesystem functionality to drive efficiency enhancements. Oversee functions that serve as the system administrators.
  • Maintain the global quality metrics dashboard, ensure metrics are accurately and consistently reported in a timely manner, and track/trend metrics across sites to monitor the company’s compliance profile and assure the effectiveness of the global qualitysystems. Collaborate with site Quality and Regulatory Affairs team to identify and implement effective and sustainable corrective actions, when needed, to address adverse trends in metrics. Issue and present trend reports and quality improvement efforts toglobal and site management.
  • Establish, implement and maintain programs to ensure audit readiness at all Quotient Sciences’ sites to achieve successful audit outcomes.
  • Support quality audits and inspections at all sites. Assess any audit observations issued to a single Quotient site to identify similar risks at other sites and lead activities to mitigate and avoid similar audit findings across sites.
  • Collaborate with site Quality and Regulatory Affairs team leaders on responses to any regulatory audit findings to assure that the response is comprehensive, timely, and will satisfy the expectations of the regulatory authority.
  • Establish and maintain auditor qualification programs to assure required personnel maintain the skills and competencies necessary to effectively conduct internal and supplier audits.
  • Collaborate with site Quality and Regulatory Affairs team to establish annual schedules for internal audits that follow risk-based approaches to assess all elements of the quality management system. Participate in one audit per year at each site to assessthe site’s Quality team.
  • Provide oversight of site investigations of critical quality issues and customer audit findings to assure thorough root cause investigation, comprehensive and accurate risk assessment and timely, effective and sustainable corrective actions.
  • Establish and maintain the company’s training and role-based qualification program. Establish standard criteria and minimum requirements for on-the-job training and associated performance assessments. Establish a Train-the-Trainer program to assure thatrequired personnel maintain the skills and competencies necessary to effectively execute training within each site. As necessary, develop quality system training material for site Quality and Regulatory Affairs team to execute locally.
  • Serve as a Quality System point of contact for all sites and provide guidance and expertise in the effective and compliant execution of the QMS at each site. As required, prepare and deliver GxP training to ensure personnel maintain the required competencyand thorough understanding of effective and compliant QMS execution.
  • Identify compliance gaps and adverse trends in quality systems and escalate events requiring immediate action to management. Lead global teams to resolve compliance issues.

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