QA Manager / Associate QA Director, QA Stakeholder Engagement Lead (SEL) - Clinical - (1720371) in Durham, NC at IQVIA™

Date Posted: 5/22/2018

Job Snapshot

Job Description

Join us on our exciting journey!IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Description

Let your career soar within Clinical QA!  We have an exciting opportunity for a QA Manager / Associate QA Director within our QA Stakeholder Engagement Lead (SEL).
 
The QA Manager / Associate QA Director will provide support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage QA oversight of projects, assignments, and training. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.

 
RESPONSIBILITIES:
  • Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions.
  • Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
  • Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures.
  • Provide consultation to customers, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans.
  • Prepare, review and approve corrective action plans
  • Present educational programs and provide guidance to operational staff on compliance procedures.
  • Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
  • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
  • Host customer audits
  • Host mock regulatory inspections and regulatory facility inspections
  • Provide training for new Quality Assurance staff
  • Serve as author of Quality Assurance SOPs as assigned
  • Advise Quality Assurance management on system audit needs
  • Act as regional or Global QA Coordinator for assigned customers projects
  • Oversee documentation, reporting, and closure of compliance issues
  • Lead Projects
  • Train new auditors and staff as required

 


Job Requirements

Bachelor’s/primary degree and 7 - 10 years Quality Assurance experience in pharmaceutical, technical, or related area; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience.
 
  • 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.
  • Exceptional training capabilities.
  • Effective organization, communication, team orientation, and leadership skills.
  • Ability to work independently with initiative.
  • Ability to manage multiple projects.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients
  • Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time.
  • Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech.
  • Occasional travel.
 
EEO Minorities/Females/Protected Veterans/Disabled

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes.

Whatever your career goals, we are here to ensure you get there!

We invite you to join IQVIA™.
Job ID: 1720371