Director, Global PV Strategy & Compliance

Acadia Pharmaceuticals; San Diego (CA); Hybrid; USD 195,000 - 243,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) Plan with company match

Equity awards

Generous PTO

Job summary

Acadia Pharmaceuticals seeks a Director of Global PV Management to translate regional and international regulatory PV requirements into robust SOPs and processes. You’ll work with cross-functional teams to ensure ongoing compliance, readiness for inspections, and implementation of regulatory changes across multiple markets.

The role emphasizes collaboration with QPPV, Regulatory, Quality, Medical Safety, and external partners to maintain PV excellence and proactive risk management.

Qualifications

• Bachelor’s degree in healthcare, life sciences or related field; 10 years PV ops/QA exp.
• Strong knowledge of global PV regs (FDA/EMA) and ICH/GVP.
• Experience representing PV in audits and CAPA.
• Proven ability to translate regulatory requirements into practical processes.
• Ability to drive cross-functional implementation and training.

Responsibilities

• Interpret international PV requirements and assess impact on procedures and outsourcing.
• Monitor changes to PV regulations and coordinate timely updates.
• Develop operational readiness plans for new markets.
• Lead gap assessments comparing regs to SOPs and practices.
• Collaborate with QPPV and country leads to ensure compliance.
• Translate regulatory requirements into actionable timelines and ownership.
• Support inspection readiness and regulatory responses.

Skills

PV regulations knowledge

PV audits & CAPA

Quality systems & SOPs

Translate regs to processes

Cross-functional collaboration

Travel willingness

PV databases

Education

Bachelor’s degree in healthcare / life sciences

Tools

PV databases

Job description

Acadia Pharmaceuticals seeks a Director of Global PV Management to translate regional and international regulatory PV requirements into robust SOPs and processes. You’ll work with cross-functional teams to ensure ongoing compliance, readiness for inspections, and implementation of regulatory changes across multiple markets.

The role emphasizes collaboration with QPPV, Regulatory, Quality, Medical Safety, and external partners to maintain PV excellence and proactive risk management.