Director, Applications, Regulated & Commercial Systems

Scorpion Therapeutics; United States; Remote; USD 120,000 - 150,000; Full time

Job summary

Scorpion Therapeutics seeks an Application Manager to support regulated GxP-compliant business applications used by Clinical Operations, Regulatory Affairs, Quality, and Pharmacovigilance. You will manage lifecycle activities, coordinate vendors, and ensure audit readiness across US and Europe.

The role includes validating systems, handling change control, and participating in CRM platform validation/deployment for future initiatives within a global biotech setting.

Qualifications

• Significant experience managing SaaS applications in biotech/pharma settings.
• Strong knowledge of GxP and validation standards.
• Familiarity with Clinical, Regulatory, Quality, or PV applications and CRM systems is advantageous.

Responsibilities

• Support regulated functions in biopharma context (GxP-compliant business applications).
• Manage application lifecycle activities, vendor coordination, validation, change control, and audit readiness.
• Collaborate with cross-functional teams across the US and Europe; support CRM platform implementation and related validation/deployment efforts.

Skills

GxP compliance

SaaS applications management

CRM systems understanding

Regulatory/Quality/PV domain knowledge

Education

Bachelor's in IT/CS or related field

Tools

CRM systems

Validation tooling

Job description

Role:

Application Manager supporting regulated functions within a biopharma context, focusing on GxP-compliant business applications used by Clinical Operations, Regulatory Affairs, Quality, and Pharmacovigilance. Responsibilities include managing application lifecycle activities, vendor coordination, system validation, change control, audit readiness, and ensuring compliance with GxP, 21 CFR Part 11, and Annex 11. The role involves collaborating with cross-functional teams across the US and Europe, supporting future CRM platform implementation, and participating in related validation and deployment efforts. The position offers an opportunity to influence the evolution of regulated and commercial applications supporting late-stage development and commercialization within a global biotech firm.

Qualifications:

Bachelor's in IT, Computer Science, or related field; significant experience managing SaaS applications in biotech/pharma settings; deep understanding of GxP and validation standards; familiarity with Clinical, Regulatory, Quality, or PV applications, and CRM systems is highly advantageous. Preferred: advanced degrees (MBA, PharmD, PhD), experience in remote US East Coast environment, and occasional travel to France.

Location:

US East Coast, remote with occasional travel.