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Global Technical Lead - Molecular

IQVIA Holdings Inc.

Valencia, California

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.

Established and productive professional individual contributor that works independently with minimal supervision. Problems faced are difficult and typically complex. Contribute to the regulatory functions associated with the operations in the Clinical Laboratory globally.

Deliver tasks associated with standardized laboratory instrumentation and testing, costings, feasibility, validations and technology transfers, proficiency testing and quality improvement. Support  global central laboratories collaborating with Laboratory,  Laboratory Standardization, Translational Science Laboratory, Scientific Review, Sales, Data Management, Quality Assurance, Information Technology team, Vendors and other business areas such as Genomics as necessary in the execution and fulfilment of duties.

Specific functions may include:

• SOPs - liaise with colleagues globally, attending global calls to harmonize processes/SOPs

• Provide technical advice and direct global discussions.

• Assist Laboratory Medical Directors with all subject-related tasks.

• Review issues arising from QC management meetings for all regions.

• Organize/oversee validation/tech transfer work globally.

• Assist and meet with Project/Set-Up Managers to discuss and advise on how to set-up new studies with complex/new testing.

• Test code creation requests

• Ensure globally aligned responses to QI’s and complaints. Complete investigations and implement global CAPAs. Ensure Effectiveness Checks are completed in all regions.

• Review CAP checklists and CAP/ISO requirements.

• Ensure global response for CAP/EQAS failure investigations/reports where appropriate.

• Attend client calls.

• Participation in audits when required.

• Promote global support from vendors.

• Complete RFTS and RFI requests.

• Organize global training for specific projects.

• Ensure global alignment on new instrument/equipment

Typically requires a minimum of 5 - 7 years of prior relevant experience.

 Requires practical knowledge in leading and managing the execution of processes, projects and tactics within their area of expertise.

Bachelor's Degree in life sciences or other relevant field - Required

10 years relevant clinical laboratory experience including at least 3 years’ experience in a leadership capacity

or equivalent combination of education, training and experience

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 posted: 2020-07-17

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