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

EY; Pittsburgh (Allegheny County); Hybrid; USD 92,000 - 153,000; Full time

Job summary

Join a leading company as a Digital Quality Transformation - Senior Consultant in Life Sciences. You will support client projects, manage validation systems, and ensure compliance with regulations. This role offers a competitive salary, comprehensive benefits, and flexible work arrangements, fostering a diverse and inclusive environment.

Benefits

Comprehensive health coverage

Pension and 401(k)

Paid time off

Flexible work arrangements

Personalized vacation policy

Qualifications

• 3+ years of related experience required.
• Experience with Life Sciences regulations and compliance.
• Strong knowledge of system validations and risk management.

Responsibilities

• Support client projects involving implementation of QMS and DMS systems.
• Manage validation lifecycle systems and conduct quality audits.
• Design and execute QMS and regulatory processes.

Skills

Life Sciences regulations

GxP processes

system validations

risk management

compliance programs

Education

Bachelor’s or master’s degree in relevant fields

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

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

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

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Location : Multiple US cities including New York, Stamford, Boston, Chicago, etc.

At EY, we’re committed to shaping your future with confidence. We support your success in a diverse, globally connected team and help you build a fulfilling career. Our Life Sciences team advises clients in biotech, pharma, medical devices, and medtech on strategic decisions to manage risks and enhance performance, ensuring patient safety.

Responsibilities

• Support client projects involving implementation of QMS, DMS, Safety, LIMS, RIM systems (e.g., Veeva, Trackwise, EtQ Reliance, Argus, Calyx).
• Manage validation lifecycle systems (e.g., ValGenesis, Kneat).
• Design and execute QMS and regulatory processes.
• Perform computer systems validation activities.
• Conduct quality audits of client processes within QMS.

Qualifications

• Bachelor’s or master’s degree in relevant fields and 3+ years of related experience.
• Experience with Life Sciences regulations, GxP processes, system validations, risk management, or compliance programs.

Preferred Skills

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

What We Offer

• Competitive salary ($92,700 - $153,000; higher in certain regions).
• Comprehensive benefits including health coverage, pension, 401(k), paid time off.
• Flexible work arrangements with a hybrid model (40-60% in person).
• Personalized vacation policy.

Join Us

Apply today to shape your future with confidence. EY values high ethical standards and integrity, fostering an inclusive environment. We are an equal opportunity employer, committed to diversity and accessibility.