Director, PV Operational Excellence

Scorpion Therapeutics; Waltham (MA); On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Travel up to 15%

Job summary

Scorpion Therapeutics in Waltham, MA is seeking a senior Pharmacovigilance quality leader to oversee PV quality systems across the product lifecycle. You will drive compliance, partner with cross-functional teams, and ensure inspection readiness.

The role requires 12+ years in PV, strong regulatory knowledge (FDA, EMA, ICH), and hands-on experience with Argus and Veeva. Occasional travel up to 15% is expected.

Qualifications

• 12+ years PV experience.
• Advanced scientific degree preferred.
• Strong knowledge of global safety regulations (FDA, EMA, ICH).
• Proficiency with safety databases (Argus, Veeva).
• MedDRA proficiency.
• Vendor management experience.

Responsibilities

• develop PV quality strategies
• manage CAPAs
• oversee vendor and system validation
• lead inspection readiness
• collaborate on training and regulatory monitoring

Skills

PV Leadership

Regulatory Affairs

Risk Management

Cross-functional Collaboration

Education

Advanced scientific degree (PhD/MD)

Tools

Argus

Veeva

MedDRA

Job description

Role

Lead pharmacovigilance quality oversight for biopharma products, ensuring compliance across the product lifecycle.

Responsibilities

• develop PV quality strategies
• manage CAPAs
• oversee vendor and system validation
• lead inspection readiness
• collaborate on training and regulatory monitoring

Qualifications

• 12+ years PV experience
• advanced scientific degree preferred
• strong knowledge of global safety regulations (FDA, EMA, ICH)
• proficiency with safety databases (Argus, Veeva)
• MedDRA
• vendor management

HighValue

PV quality systems, vendor oversight, global compliance, inspection readiness, and regulatory intelligence.

WorkSetup

office-based in Waltham, MA, with up to 15% travel.