Digital Quality Transformation - Senior Consultant - Life Sciences (QMS)

EY; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

EY is seeking a Digital Quality Transformation - Senior Consultant in Life Sciences to join their Risk Consulting Services team. This role involves advising clients in biotech and pharma, focusing on quality management and regulatory compliance. Candidates should have a degree in a related field and relevant experience, with opportunities for career growth in a supportive and inclusive environment.

Benefits

Competitive salary range

Flexible work arrangements

Supportive, inclusive culture

Qualifications

• At least three years of relevant experience in life sciences.
• Experience in life sciences regulatory statutes, GxP processes, system validations, or risk management.

Responsibilities

• Support client projects implementing QMS, DMS, Safety, LIMS, and RIM systems.
• Manage validation lifecycle systems.
• Design and execute QMS and regulatory processes.
• Perform computer systems validation activities and quality audits.

Skills

Quality Management Systems (QMS)

Regulatory Affairs

Laboratory Information Management Systems

Computer Systems Validation

Education

Bachelor’s or Master’s degree in a related field

Tools

Veeva Vaults

LIMS

Validation Lifecycle Management Systems

Job description

Digital Quality Transformation - Senior Consultant - Life Sciences (QMS)

Join to apply for the Digital Quality Transformation - Senior Consultant - Life Sciences (QMS) role at EY.

This position is located in various cities across the US, including New York, Stamford, Boston, and others. EY is committed to building a better working world through diverse, inclusive teams that help clients achieve high performance while ensuring patient safety in the life sciences sector.

About the Role

You will be part of the Life Sciences Risk Consulting Services team, advising clients in biotech, pharma, medical devices, and related industries. Your work will involve developing and implementing systems and processes to manage quality, regulatory, and compliance risks, including:

• Quality Management Systems (QMS)
• Regulatory Affairs
• Laboratory Information Management Systems
• Computer Systems Validation

Key Responsibilities

• Support client projects implementing QMS, DMS, Safety, LIMS, and RIM systems
• Manage validation lifecycle systems
• Design and execute QMS and regulatory processes
• Perform computer systems validation activities and quality audits

Qualifications

• Bachelor’s or Master’s degree in a related field with at least three years of relevant experience
• Experience in life sciences regulatory statutes, GxP processes, system validations, or risk management

Preferred Skills

• Experience with Veeva Vaults, LIMS, Validation Lifecycle Management Systems

What We Offer

Competitive salary range, benefits, flexible work arrangements, and a supportive, inclusive culture. Salaries vary based on location and experience, with specific ranges provided for different regions.

Join Us

If you're passionate about helping businesses deliver value and serve patients, apply today. EY is committed to high ethical standards and diversity, providing accommodations for qualified individuals with disabilities.