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Associate Director, Quality Assurance - Home Based - UK

Employer
IQVIA
Location
Reading
Start date
23 Sep 2022
Closing date
22 Oct 2022

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Discipline
Quality, Auditor, GCP, Systems Manager
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

Job Overview
This role is strategic in nature with focus on innovation of the Quality Management System (QMS) across the organization, including but not limited to technology in use by Quality Assurance (QA). This position will have responsibility for a variety of QMS processes and software, driving that along with any augmentation that is required to drive the products and data strategy, such as Data Analytics, Sponsor Audit Defense, Inspection Management, and Virtual Offerings. Provide insight which is exercisable across the large part of the organization or by managing a team and influencing outcomes. Oversee & coordinate assigned QA QMS at a regional and/or global level, QA program in support of customer accounts, functional accounts, audit and inspection program. Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, Quality, Process, productivity/efficiency improvement initiatives. Act as line manager for one or more QA staff and oversee development and departmental deliverables. Manage the quality assurance oversight of projects, assignments, training and staff.

Essential Functions

  • Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
  • Participate in or lead (cross functional) teams for special projects as assigned.
  • Promote the concept of quality, the principles of quality management and devise and implement quality improvements.
  • Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies.
  • Manage staff, including planning, assigning, & directing work, appraising performance, guiding professional development, rewarding and disciplining employees, addressing employee relations issues & resolving problems. Approve actions on human resources matters.
  • Plan, schedule, conduct, report and close audit activities, as assigned.
  • Provide Quality Assurance support, guidance and management of Quality Issues, as assigned.
  •  Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management.
  •  Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce.
  • Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
  • Host customer audits and participate in review of corrective action plans, as assigned
  • Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits.
  •  Serve as the QA Contact for assigned internal/external customers and IQVIA functional areas.
  • Oversee documentation, reporting, and closure of compliance issues.
  • Support Quality Management in proposal reviews and reporting QA metrics.
  • Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned.
  • Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned.

    Qualifications
    • Bachelor's Degree Preferable
    • 10 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience. 3 years of management experience. Equivalent combination of education, training and experience.
    • Knowledge of word-processing, spreadsheet, and database applications.
    • Strong knowledge of pharmaceutical research and development processes and regulatory environments.
    • Considerable knowledge of quality assurance processes and procedures.
    • Strong interpersonal skills.
    • Excellent problem solving, risk analysis and negotiation skills.
    • Effective organization, communication, and team orientation and leadership skills.
    • Ability to influence and guide others.
    • Ability to manage costs effectively through appropriate resource allocation.
    • Management experience in Quality Assurance.
    • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

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