Senior Consultant - Life Sciences Quality Transformation

EY; Houston (TX); Hybrid; USD 94,000 - 176,000; Full time

Job summary

EY Life Sciences Risk Consulting Services seeks professionals to help clients identify, manage, and respond to risks while accelerating performance and maintaining growth in biotechnology, pharmaceutical, and medical device sectors.

You will work on implementing QMS, DMS, LIMS, and validation systems, supporting client engagement teams and ensuring high-quality deliverables in a hybrid work environment.

Qualifications

• Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a 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.
• Ideally, experience in implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems.

Responsibilities

• Your time will be spent supporting client engagement teams to deliver projects in the life sciences domain, including: Implementation of QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in the roles of business process analyst, technical writer, project manager, computer systems validation, and other business / project roles associated with delivery and execution.
• Implementation of validation lifecycle management systems (e.g. ValGenesis, Kneat)
• Design and execution of QMS and Regulatory processes.

Education

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

Tools

Veeva Vaults

LIMS

Validation Lifecycle Management Systems

Job description

EY Life Sciences Risk Consulting Services seeks professionals to help clients identify, manage, and respond to risks while accelerating performance and maintaining growth in biotechnology, pharmaceutical, and medical device sectors.

You will work on implementing QMS, DMS, LIMS, and validation systems, supporting client engagement teams and ensuring high-quality deliverables in a hybrid work environment.