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Associate Director, QA (R1036666) in Durham, NC at IQVIA™

Date Posted: 5/2/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Durham, NC
  • Experience:
    Not Specified
  • Date Posted:
    5/2/2019
  • Job ID:
    R1036666

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.

The Associate Director, QA will 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. Act as line manager for one or more QA staff.

Responsibilities:

  • Provide guidance, interpretation, support, training, and key input to clinical development operational staff on interpretation of applicable regulations, guidelines, corporate standards, and policies.
  • Host customer audits and participate in review of corrective action plans.
  • Recommend systems for audit, write systems and procedures audit plans and coordinate scheduling, conduct, reporting and closure of internal systems and procedures audits.
  • Plan, schedule, conduct, report and close audits of laboratory activities.
  • Serve as QA Contact for assigned customers and functional areas.
  • Oversee documentation, reporting, and closure of compliance issues.
  • Track, trend, and report Quality Metrics for the site.
  • Support Director in proposal reviews and reporting QA metrics.
  • Conduct trend analysis of audit findings and Quality Issues and provide QA management with initial root cause analysis
  • Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections.
  • Recommend staff management actions in accordance with organization’s policies and applicable laws.
  • Recommendations include training, coaching, and mentoring employees; planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.


Minimum Requirements

  • Bachelor’s/primary degree in life sciences or medically related field; or equivalent paramedical qualifications; with 7-10 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP, CAP/CLIA Quality
  • Assurance experience. A minimum of 3 years of management experience; or 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.

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: R1036666