Associate Director, GVP Compliance

Scorpion Therapeutics; United States; Hybrid; USD 120,000 - 180,000; Full time

Job summary

BioMarin is seeking a Pharmacovigilance (PV) Compliance Lead within Global Quality to drive GVP compliance, lead audits and inspections, and strengthen regulatory readiness across PV programs. You will guide stakeholders, mitigate compliance risks, and contribute to PV systems and REMS oversight, ensuring robust PV governance.

This role offers remote-friendly arrangements with up to 25% travel and opportunities to influence cross-functional PV strategies in a global context.

Qualifications

• 8+ years in regulated healthcare environments.
• Expertise in FDA and EMA PV regulations including GVP and GCP.
• Experience managing inspections and audits in PV areas.
• Strategic thinker with strong communication skills.

Responsibilities

• Advise stakeholders on GVP practices and PV compliance.
• Conduct PV audits and support regulatory inspections readiness.
• Mitigate compliance risks across PV processes and systems.
• Contribute to PV systems enhancements and REMS oversight.

Skills

GVP compliance

FDA PV regulations

EMA PV regulations

GCP

audits and inspections

regulatory risk management

stakeholder advisory

Job description

Role:

Pharmacovigilance (PV) Compliance Lead within Global Quality at BioMarin, focusing on GVP compliance, audits, and regulatory inspections.

Responsibilities:

advise stakeholders on GVP practices, conduct audits, support inspection readiness, mitigate compliance risks, and contribute to PV systems and REMS programs.

Requirements:

8+ years in regulated healthcare, expertise in FDA, EMA PV regulations, GVP, GCP, and experience in managing inspections and audits; strategic thinker with strong communication skills.

HighValue:

PV compliance, GVP audits, regulatory inspections, global PV regulations, Pharmaceutical quality systems, post‑marketing surveillance, REMS oversight.

WorkSetup:

up to 25% travel, remote‑friendly.