Associate Director, Automation - (R1023428) in Research Triangle Park, NC at IQVIA™

Date Posted: 5/24/2018

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

Job Summary: 
Responsible for the identification, acquisition and implementation of laboratory automation solutions in a dynamic, high-throughput genomic laboratory specializing in clinical trial testing. Will direct a team to carry out this work, and will work directly with Laboratory Operations, Assay Development, and other internal stakeholders to understand requirements and identify opportunities to deploy automation solutions. Responsible for developing budgets and tracking ongoing costs, establishing and adhering to time-bound project plans, maintaining regulatory compliance, and communicating progress to internal stakeholders.

Duties and Responsibilities
  • Adhere to all Q Squared Solutions policies, procedures and employee handbook contents.
  • Direct the Laboratory Automation Group, and contribute to the leadership and management of the Translational Genomics group, as directed.
  • Gain a deep understanding of current laboratory processes and procedures; design and engineer revised processes.
  • Interface directly with internal clients in Laboratory Operations, Assay Development and Information Technology to identify opportunities for automation solutions, to determine requirements, and to coordinate activities accordingly.
  • Directly and through staff, determine an appropriate level of testing, verification and/or validation for new automation platforms and methods, and develop corresponding plans and summary reports commensurate with Quality Systems requirements.
  • Responsible for projecting capacity, costs, personnel, equipment, reagents and time requirements for solutions being developed or implemented, including ongoing calibration and maintenance where required.
  • Identify quality control metrics useful for the initial and ongoing evaluation of new processes. Monitor and refine QC metrics to ensure that automated methods remain in statistical control.
  • Critically review new technology on an ongoing basis to understand suitability towards Q Squared Solutions business strategy.
  • Ensure that all laboratory automation equipment is maintained and calibrated as required.
  • Function in a team environment, recognizing that priorities will shift according to business needs and maintain a flexible work schedule.
  • Other duties, as assigned.

Job Requirements

Knowledge, Skills, and Abilities
  • Working knowledge of GxP, CLIA and HIPAA requirements.
  • Demonstrated familiarity with contemporary molecular genomic technologies.
  • Excellent planning and organizational skills, and close attention to detail are essential.
  • Direct experience managing high-performing teams and developing team members.
  • Capable of managing multiple projects simultaneously.
  • Superior oral and written communications skills.
  • Proficient user of standard office productivity software such as Microsoft Word, Excel and PowerPoint, along with basic statistical analysis.
  • Direct experience interfacing automation systems with laboratory software systems including LIMS is strongly preferred.
Qualifications:
  • BS or greater in Engineering, Molecular Genetics or related field
  • Minimum of 8 years of experience in automation, with significant experience in a laboratory setting.
  • At least 5 years of experience building, developing and managing a team.
  • Experience in a clinical laboratory operating under GxP and/or CLIA guidelines and direct experience with clinical trials is preferred
 
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: R1023428