Associate Director, International GVP Compliance

Scorpion Therapeutics; Boston (MA); On-site; USD 154,000 - 243,000; Full time

Benefits offered by this job

Benefits info via application

Job summary

Scorpion Therapeutics in Cambridge, MA seeks an Associate Director, International GVP Compliance to lead regional GVP strategies, ensure consistent interpretation of regulations, and maintain inspection readiness.

The role requires BSc, 7+ years in pharma/healthcare and 4+ years in PV quality/compliance, plus strong knowledge of GVP regulations and experience with audits and inspections.

Qualifications

• Required: Scientific/allied health qualification (BSc).
• Preferred: Advanced degree.
• 7+ years in pharma/healthcare; 4+ years in Pharmacovigilance Quality/Compliance/PV operational roles.
• Strong knowledge of GVP regulations (EU GVP Modules, ICH E2, US CFR) and regional authority expectations.
• Experience with GVP audits/inspections, investigations, and remediation.
• Strong analytical/problem-solving (risk-based thinking), communication, organization, and ethical standards.

Responsibilities

• Lead regional implementation of global GVP compliance strategies across LOCs; ensure consistent interpretation of regulations and Takeda standards.
• Serve as regional GVP subject-matter expert; guide LOC and regional stakeholders on regulatory expectations, quality system requirements, and inspection readiness.
• Execute/support GVP Quality System processes: deviations, investigations, CAPA management, change control, and escalation.
• Lead high-quality investigations and root-cause analysis; ensure patient-safety focus and prevention of recurrence.
• Track/monitor CAPA development, implementation, and effectiveness; elevate risks, delays, or systemic issues.
• Manage inspection readiness and lead regional/LOC audits and regulatory inspections (preparation, conduct, response, follow-up).
• Partner with Director, Regional GVP Compliance, EU QPPV and PSPV for aligned inspection messaging, issue tracking, and corrective actions.
• Proactively identify/assess compliance risks using audit outcomes, inspection findings, KQIs, and compliance data; support governance and management review materials.
• Support continuous improvement; develop/refine training and compliance guidance; harmonize practices across LOCs.

Skills

GVP knowledge

Audit & inspection experience

Regulatory alignment

Risk-based thinking

Strong communication

Education

BSc

Advanced degree

Job description

Associate Director, International GVP Compliance (Cambridge, MA)

Responsibilities / Accountabilities

• Lead regional implementation of global GVP compliance strategies across LOCs; ensure consistent interpretation of regulations and Takeda standards.
• Serve as regional GVP subject-matter expert; guide LOC and regional stakeholders on regulatory expectations, quality system requirements, and inspection readiness.
• Execute/support GVP Quality System processes: deviations, investigations, CAPA management, change control, and escalation.
• Lead high-quality investigations and root-cause analysis; ensure patient-safety focus and prevention of recurrence.
• Track/monitor CAPA development, implementation, and effectiveness; elevate risks, delays, or systemic issues.
• Manage inspection readiness and lead regional/LOC audits and regulatory inspections (preparation, conduct, response, follow-up).
• Partner with Director, Regional GVP Compliance, EU QPPV and PSPV for aligned inspection messaging, issue tracking, and corrective actions.
• Proactively identify/assess compliance risks using audit outcomes, inspection findings, KQIs, and compliance data; support governance and management review materials.
• Support continuous improvement; develop/refine training and compliance guidance; harmonize practices across LOCs.

Qualifications (Required/Preferred)

• Required: Scientific/allied health qualification (BSc).
• Preferred: Advanced degree.
• Required: 7+ years in pharma/healthcare; 4+ years in Pharmacovigilance Quality/Compliance/PV operational roles.
• Strong knowledge of GVP regulations (EU GVP Modules, ICH E2, US CFR) and regional authority expectations.
• Experience with GVP audits/inspections, investigations, and remediation.
• Strong analytical/problem-solving (risk-based thinking), communication, organization, and ethical standards.

Compensation/Benefits

• U.S. base salary range (Boston, MA): $154,400.00–$242,550.00.
• Benefits info available via link upon application.