8 часов назад
Director, GPV Compliance & Business Management (QA)
186 489 - 278 875$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Director, GPV Compliance & Business Management (QA) (Pharmacovigilance Quality and Compliance): Leading global pharmacovigilance compliance systems, audit and inspection readiness, CAPA and deviation management, and vendor oversight with an accent on GxP quality systems, regulatory alignment, and cross-functional governance. Focus on designing inspection-readiness strategies, solving systemic compliance issues through root-cause analysis and remediation, and driving sustainable quality improvements across global PV operations.
Location: Princeton, New Jersey, United States
Salary: $186,489–$278,875 annually, plus incentive opportunity.
Company
Pharmaceutical Companies supports pharmaceutical development and commercial operations, including global pharmacovigilance and quality activities.
What you will do
- Lead the strategic direction and governance of global pharmacovigilance compliance systems in alignment with regulatory standards.
- Direct global PV audit and inspection readiness, including planning, coordination, regulatory liaison, and post-inspection remediation.
- Oversee CAPA, deviation, temporary change control, and standalone CAPA processes, ensuring effective investigations and timely closure.
- Guide root-cause analysis, impact assessment, risk mitigation, and sustainable corrective actions for PV compliance issues.
- Manage vendor performance and oversee alliance company and service-provider PV audit activities.
- Collaborate with Global Quality, Regulatory Affairs, Clinical Management, affiliates, regional PV offices, and external pharmaceutical organizations.
Requirements
- Bachelor's degree.
- At least 6 years of pharmacovigilance compliance or pharmaceutical quality management experience, or relevant leadership experience.
- Experience working in a global setting and managing vendor relationships and oversight.
- Knowledge of ICH, U.S. and EU pharmacovigilance regulations, GVP, GCP, and inspections conducted by agencies such as the FDA and MHRA.
- Experience with pharmaceutical quality compliance management systems and PV audits.
- Strong project management, communication, presentation, strategic thinking, and influencing skills, with proficiency in Microsoft Office.
Culture & Benefits
- Global, cross-functional work across affiliates, partner organizations, and regional PV offices.
- Responsibility for leading internal colleagues and managing an external vendor team.
- Medical, dental, vision, prescription drug, life, and disability insurance.
- Tuition reimbursement, student loan assistance, and a company 401(k) match.
- Flexible time off, paid holidays, and paid leave programs.
- Travel may be required as applicable.
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