Director, Quality Assurance (R1108412) in Ithaca, NY at IQVIA™

Date Posted: 2/9/2020

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Ithaca, NY
  • Experience:
    Not Specified
  • Date Posted:
    2/9/2020
  • Job ID:
    R1108412

Job Description

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, Q2 Solutions uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.  A joint venture of IQVIA (formerly QuintilesIMS) and Quest Diagnostics, Q2 Solutions combines the best of each parent organization’s clinical trials laboratory services capabilities to fulfill its mission of treating each sample as if a life depends on it.

Purpose

Oversee and coordinate the quality assurance program for assigned customer projects at a regional and/or global level.  Provide support in the promotion and assessment of compliance with regulations, guidelines, and operating procedures among sites within the region and globally as assigned.  Act as line manager for one or more QA staff.  Serve as primary back-up for QA management.

Responsibilities

  • Plan, schedule, conduct, report and close audit activities in any of the countries involved with corporate contracts.
  • Assist in establishment of quality assurance and control policy by providing consultation and recommendations to regional and Global QA Management
  • Serve as author for QA SOPs and may act as regional QA representative to the global QA SOP taskforce
  • Serve as QA representative on Global SOP Taskforce(s) for other IQVIA functional areas as assigned
  • Participate in or lead teams for special projects as assigned.  Teams may be cross functional.
  • 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.  Recommend systems for audit, write systems audit plans and coordinate scheduling, conduct, reporting and closure of internal system audits.
  • Serve as Global QA Contact for assigned customers and IQVIA functional areas.
  • Oversee documentation, reporting, and closure of compliance issues.
  • Support QA Management in proposal reviews and reporting QA metrics.
  • Act as primary back-up for QA management.
  • Conduct trend analysis of audit results and provide QA management with initial root cause analysis.
  • May present trend analysis results and QA metrics to IQVIA upper management.
  • Ensure proper coordination of customer-initiated audits and mock regulatory inspections and manage regulatory facility inspections.
  • Manage staff in accordance with organization’s policies and applicable regulations.  Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.  Approve actions on human resources matters.

Required Knowledge, Skills and Abilities

  • Knowledge of word-processing, spreadsheet, and database applications.
  • Extensive 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 skills
  • Senior Management experience in Quality Assurance
  • Ability to influence and guide others at all levels of management.
  • Demonstrated ability to lead and manage multiple responsibilities.
  • Ability to manage costs effectively through appropriate resource allocation.
  • Ability to articulate and define departmental needs and processes.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

Minimum Required Education and Experience

  • 12 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience,
  • 5 years of management experience                   
  • Bachelor’s degree required or equivalent combination of education, training and experience

What We Offer

  • Major Medical, Vision, Dental, Disability
  • Annual bonus
  • 401(k) with 100% with immediate vesting
  • Tuition Reimbursement up to $6k annually
  • Generous paid time off and holiday leave
  • Other generous benefits

EEO Minorities/Females/Protected Veterans/Disabled

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1108412

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