Associate Director, QA - (R1036666) in Research Triangle Park, NC at IQVIA™

Date Posted: 10/19/2018

Job Snapshot

Job Description

Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities.

Description

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.

Job Requirements


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.
 
 
EEO Minorities/Females/Protected Veterans/Disabled

 
 
EEO Minorities/Females/Protected Veterans/Disabled

Job ID: R1036666