Senior Life Sciences Quality & Regulatory Transformation

EY; Atlanta (GA); Hybrid; USD 94,000 - 155,000; Full time

Job summary

EY’s Life Sciences Risk Consulting Services team helps biotechnology, pharmaceutical, medical device manufacturers address risks while accelerating performance and growth. You will implement QMS, DMS, LIMS, and regulatory processes, perform validation activities, and conduct quality audits as part of cross-functional teams, with travel up to 40% in a full-time role.

Ideal candidates hold a bachelor’s or master’s degree in a related field with 3+ years of Life Sciences experience, including

Qualifications

• Bachelor’s or master’s degree in Computer Science, Biomedical Engineering, Quality Engineering, Manufacturing or a related field with at least three years of related work experience.
• 3+ years of Life Sciences experience, including working with Life Science regulatory statutes, GxP processes or system validations, risk management or compliance programs.
• Experience implementing Veeva Vaults (Quality, Clinical, Regulatory, Safety), LIMS, and/or Validation Lifecycle Management Systems.

Responsibilities

• Implement QMS, DMS, Safety, LIMS, and RIM systems (e.g. Veeva, Trackwise, EtQ Reliance, Argus, Calyx) in roles such as business processes analyst, technical writer, project manager, computer systems validation, and related delivery activities.
• Implement validation lifecycle management systems (ValGenesis, Kneat).
• Design and execution of QMS and Regulatory processes.
• Perform computer systems validation activities as part of a service.
• Perform quality audits of client processes within the QMS area.

Skills

QMS implementation

Regulatory affairs

GxP knowledge

LIMS

DMS

Validation lifecycle

Education

Bachelor's or Master's in related field

Tools

Veeva Vaults

ValGenesis

Kneat

Trackwise

EtQ Reliance

Argus

Calyx

Job description

EY’s Life Sciences Risk Consulting Services team helps biotechnology, pharmaceutical, medical device manufacturers address risks while accelerating performance and growth. You will implement QMS, DMS, LIMS, and regulatory processes, perform validation activities, and conduct quality audits as part of cross-functional teams, with travel up to 40% in a full-time role.

Ideal candidates hold a bachelor’s or master’s degree in a related field with 3+ years of Life Sciences experience, including