Associate Director, Global PV Product Complaint Management & Oversight

Scorpion Therapeutics; Chapel Hill (NC); Hybrid; USD 170,000 - 210,000; Full time

Job summary

Scorpion Therapeutics in Durham, NC seeks an Associate Director to lead the Global PV Product Complaint Management & Oversight, spanning devices, drugs, biologics, and combination products. This role governs end-to-end case processing and drives global procedures while ensuring adherence to EU MDR, IMDRF, 21 CFR, and ISO standards across lifecycle stages.

You will guide audits, CAPAs, and safety governance, managing cross-functional teams and vendor relationships to sustain continuous

Qualifications

• Bachelor's or higher degree in a relevant field.
• 7+ years' pharmacovigilance or product complaint experience supporting devices, biologics, or combination products.
• Experience with vendor oversight, post-marketing drug exposure, and safety databases (preferably Argus).

Responsibilities

• Oversee complaint handling processes.
• Develop and implement global procedures.
• Ensure compliance with international regulations (EU MDR, IMDRF, 21 CFR, ISO standards).
• Lead inspection readiness.
• Foster continuous improvement in safety governance.
• Manage cross-functional teams and vendor relationships.
• Provide training.
• Lead audits and CAPAs.

Skills

GMP/GDP knowledge

ISO standards

Global regulatory requirements

End-to-end case processing

Vendor management

Inspection readiness

Education

Bachelor's degree in a relevant field

Master's degree or PharmD

Tools

Argus

Job description

Role

Associate Director, Global PV Product Complaint Management & Oversight, leading the global governance of product complaints across devices, drugs, biologics, and combination products throughout all lifecycle stages.

Responsibilities

• oversee complaint handling processes
• develop and implement global procedures
• ensure compliance with international regulations (EU MDR, IMDRF, 21 CFR, ISO standards)
• lead inspection readiness
• foster continuous improvement in safety governance
• Manage cross-functional teams and vendor relationships
• provide training
• lead audits and CAPAs

Qualifications

• Bachelor's or higher degree in a relevant field
• 7+ years' pharmacovigilance or product complaint experience supporting devices, biologics, or combination products
• experience with vendor oversight, post-marketing drug exposure, and safety databases (preferably Argus)

Core Skills

• deep knowledge of GMP/GDP
• ISO standards
• global regulatory requirements
• end-to-end case processing

Preferred

Master's degree or PharmD.

High-Value

• global pharmacovigilance
• product complaint oversight
• regulatory compliance
• medical device/software safety
• vendor management
• inspection readiness

Location

Durham, NC with hybrid work; travel as needed.