GxP Quality & Process Excellence Manager, Global Development

Scorpion Therapeutics

New Jersey

Hybrid

USD 120,000 - 160,000

Full time

10 days ago

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Job summary

Scorpion Therapeutics in New Jersey seeks a Manager, Process & Personnel Qualification Management Expert in R&D Quality to drive compliance and quality excellence across pharmaceutical development. You will lead process improvement, strengthen GxP frameworks, and partner with Global Development while guiding data-centric qualification systems; hybrid/remote with international scope.

The role demands 5+ years in pharma/device compliance, strong leadership and communication, and a track record of

Qualifications

Bachelor's in Science or Business; Master's preferred.
5+ years in pharmaceutical/device compliance within a matrix org.
Strong knowledge of global clinical safety, pharmacovigilance, and regulatory standards.
Excellent communication, project management, and analytical skills.
Proven leadership and collaboration abilities.

Responsibilities

Lead process improvement projects including process mapping, training development, and qualification.
Serve as a quality partner for Global Development; adapt GxP to regulatory changes.
Support digital transformation to create data-centric qualification systems.
Manage timelines, risks, issues, and stakeholder communication.
Potentially lead audits and inspections.