Senior Director, Quality Assurance (R1078939) in Reading, UK at IQVIA™

Date Posted: 6/20/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Reading, UK
  • Experience:
    Not Specified
  • Date Posted:
    6/20/2019
  • Job ID:
    R1078939

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.



Senior Director Quality Assurance

Location – Reading, UK

Salary – Competitive Salary and benefits

Closing Date – 19 July 2019



Summary

The Sr. Director QA assumes the role of QA Stakeholder Engagement Lead (SEL), Team Leader and a Line Manager for the European and AsiaPac region SEL.  The role will have Line Management responsibilities for a large team as well as capability to take on the role of a Strategic SEL for one or more important IQVIA customers.  Travel is required in this position and may include some international travel.



Description

The SEL role assumes ownership the following activities for the assigned customers:

  • Collaborates with Quality counterparts at customers and with internal project teams to proactively promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities.
  • Provides actionable insights from quality and operational data analysis and proactively working with the customer and the account team to develop action plans to drive continuous improvement.
  • Analyses trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams
  • Supports the management and resolution of significant issues relating to quality;
  • In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage.
  • Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer
  • Contributes to the development of the global risk-based internal audit plan.
  • Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites.
  • Prepares for and actively participates in relevant Governance/partnership level meetings e.g. Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts.
  • Interfaces with senior management to discuss quality and compliance issues
  • Interfaces with business development and operations to identify business opportunities
  • Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.

The SEL, Team Lead is responsible for:

  • Overseeing staff in developing and delivering proactive quality approaches designed to facilitate compliance, supporting ongoing inspection readiness, and managing significant quality issues.
  • Identifying and disseminating best practices in customer engagement and quality oversight to enhance our customer relationships.
  • Developing internal talent through cost-efficient educational and developmental activities that enhances the succession-planning process. 
  • Managing staff performance, utilization, efficiency and revenue recognition
  • Preparing for and actively participating in Governance/partnership level meetings with customers including Executive Steering Committees  
  • Collaborating with Inspection Strategy and Audit partners to ensure risk-based audit coverage of projects and to drive successful customer audits and project-related inspections. 


Required Knowledge, Skills and Abilities

  • Extensive, demonstrable knowledge of pharmaceutical research and development processes and regulatory environments.
  • Considerable demonstrable knowledge of quality assurance processes and procedures.
  • Strong interpersonal skills with the ability to influence and guide others.
  • Excellent problem solving, risk analysis and negotiation skills.
  • Effective organization, communication, and team orientation skills.
  • Ability to establish and maintain effective working relationships with co-workers, managers and clients
  • Knowledge and working experience of word-processing, spreadsheet, and database applications.


Minimum Required Education and Experience

  • Bachelor’s degree
  • Extensive, demonstrable experience in pharmaceutical, technical, quality assurance, or related area, including management experience; or equivalent combination of education, training and experience
  • Team management experience is a pre-requisite due to size of team in this role

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.



Job ID: R1078939