Life Sciences Quality Transformation Consultant

EY; Wichita (KS); Hybrid; USD 94,000 - 176,000; Full time

Benefits offered by this job

Hybrid work model

Medical and dental coverage

Pension and 401(k)

Job summary

EY’s Life Sciences Risk Consulting Services is seeking professionals to support client engagements in the biopharma, medical device, and regulatory domains. You will help identify, manage, and respond to risks while accelerating performance and maintaining growth, aligning risk with business objectives across strategy to execution.

Full-time employment with travel up to 40% and a hybrid work model. EY offers a comprehensive compensation package including medical, dental, and retirement benefits,

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or related field.
• 3+ years of Life Sciences work experience, including working with Life Science regulatory statutes, GxP business processes or system validations, risk management or compliance programs or integration of risk management functions.

Responsibilities

• Support client engagement teams to deliver projects in the life sciences domain.
• Implement QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx).
• Design and execute QMS and Regulatory processes.
• Perform computer systems validation activities as part of a service.
• Perform Quality audits of client processes within the QMS area.

Education

Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or related field

Tools

Veeva Vaults

LIMS

ValGenesis

Kneat

Trackwise

EtQ Reliance

Argus

Calyx

Job description

EY’s Life Sciences Risk Consulting Services is seeking professionals to support client engagements in the biopharma, medical device, and regulatory domains. You will help identify, manage, and respond to risks while accelerating performance and maintaining growth, aligning risk with business objectives across strategy to execution.

Full-time employment with travel up to 40% and a hybrid work model. EY offers a comprehensive compensation package including medical, dental, and retirement benefits,