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Manager, BioServices Project Management (R1073863) in Marietta, GA at IQVIA™

Date Posted: 5/2/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Marietta, GA
  • Experience:
    Not Specified
  • Date Posted:
    5/2/2019
  • Job ID:
    R1073863

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.

Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide bio-specimen 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 Manager, BioServices Project Management is the senior level project management position and has management responsibility for lower level Project Managers and Project Leaders. Act as an authoritative resource regarding the proper procedures and techniques required of the Project Management discipline. Demonstrate a high level of responsibility for the conduct of projects and play an active role mentoring and guiding junior members of the project management team. Act as the primary point of contact for Q2 Solutions’ external customers, providing exceptional customer service while ensuring that all work meets Q2 Solutions’ scientific standards, continually seeking out better ways to plan and execute projects. Provide a strong leadership presence throughout the organization driving quality science and process improvements.

RESPONSIBILITIES

  • Provide oversight and conduct of a project throughout its life at Q2 Solutions, including immunoassay method development, method validation, and sample analysis.
  • Serve as Principal Investigator for bioanalytical phase of GLP animal studies.
  • Provide leadership for Technical Writing, QC and QA to ensure projects are completed on schedule.
  • Review validation and bioanalytical reports for completeness.
  • Maintain a strong leadership presence throughout the organization by driving scientific quality, PMO team development and process improvement initiatives.
  • Maintain all communication with customers providing daily updates on all active projects while being vigilant for opportunities to earn additional business.
  • Work with the customer to resolve sample demographic discrepancies.
  • Monitor the progress of all assigned projects and alert management if work falls behind schedule.
  • Provide regular project status updates to management.
  • Participate in weekly scheduling and revenue update meetings and provide updates on project progress.
  • Prepare bioanalytical immunoassay method validation and sample analysis plans.
  • Review analytical method summaries for completeness
  • Review data (analytical runs, documentation, data tables, reports) for regulatory compliance and scientific quality.
  • Address issues from QC and QA review for run binders.
  • Conduct thorough investigations of all failed runs.
  • Lead method troubleshooting investigations. Identify and assemble technical resources and compose investigation reports.
  • Prepare appropriate and effective corrective and preventative action plans (CAPAs) for assigned projects.
  • Host customer visits, lead scientific and business discussions and be SME for regulatory inspections.
  • Visit customer sites to discuss ongoing projects and future business possibilities
  • Work with business development staff to prepare quotes for assigned customers.
  • Work towards designing and implementing process improvement initiatives.
  • Approve method validation experimental designs.
  • Prepare data for external presentations.
  • Manage staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems; and approving actions on human resources matters.
  • Ensure projects are archived in accordance with Q2 Solutions SOP.
  • Responsible for upholding all safety standards, discipline guidelines and regulatory compliance requirements with all assigned staff.
  • Comply with all applicable regulatory standards, including Good Clinical and Good Laboratory Practices.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Have a broad bioanalytical knowledge base
  • Ability to achieve results through collaborative efforts with others.
  • Depth of understanding of Immunoassay techniques.
  • Experienced in sample testing and routine laboratory procedures.
  • Understanding of method development and validation of assays
  • Ability to interact with external and internal clients, and work to objectives/timelines
  • Excellent attention to detail and communication skills
  • Ability to provide verbally communicated or draft procedures
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s Degree in a scientific field with 7 years’ related experience; or equivalent combination of education, training and experience in GLP laboratory environment.

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: R1073863