undefined
About the role
- Head of PV and Regulatory QA leading compliance for global pharmacovigilance system. Overseeing strategic governance, operational excellence, and regulatory intelligence with a focus on quality assurance.
Responsibilities
- Direct the strategic development of the Global PVRQA function, supporting both the global R&D business and regional affiliates.
- Harmonize processes within Global PVRQA and across other GxP areas.
- Own the long-term, risk-based audit strategy and deliver annual internal and external audit programs covering global systems, affiliates, and third-party vendors.
- Lead the preparation, conduct, and response phases for PV health authority inspections and third-party audits.
- Monitor PV system health through oversight of deviation management, CAPA, change management, and performance reporting (KPIs).
- Provide GVP consultancy and cross-GxP expertise to ensure coordination across functional areas, including Commercial and Clinical Development.
- Oversight of PV IT systems, procedural quality assurance (SOPs), and third-party/vendor management.
- Direct budget development and resource allocation by strategically assessing workload and coordinating consultant activities.
- Monitor global regulatory trends and methodologies to implement improvement initiatives in response to the evolving landscape.
Requirements
- Undergraduate degree (BA/BS) in a Scientific or Life Sciences discipline; an advanced degree is preferred.
- 10+ years of pharmaceutical industry experience specifically within Quality Assurance.
- Proven experience in a senior leadership capacity with deep knowledge of GVP/GCP regulations and international pharmacovigilance guidelines.
- Extensive understanding of end-to-end pharmacovigilance processes, including Deviation/CAPA management and the conduct of clinical research.
- Experience working within global, cross-functional teams and managing complex regulatory interactions.
- The ability to quickly analyze complex circumstances and drive appropriate decisions and actions.
- Excellent communication, negotiation, and influencing skills across all levels of the business.
- Strong organizational skills with a focus on customer service and the ability to manage complex budgets and resourcing plans.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Professional development opportunities
- Flexible working arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
Checker, Cleanroom Tech inspecting parts for machinery quality assurance. Collaborating with the quality team and managing data using SAP.
GCP Director ensuring compliance in clinical trials for Evolution Research Group. Overseeing quality assurance and operations at the Clinical Pharmacology of Miami site.
QA Engineer managing Corrective and Preventive Action program in compliance with regulatory standards. Supporting Quality Management System activities in the Medical Device industry.
Quality Engineer ensuring compliance in aerospace projects, leading audits and design assurance implementation for aviation products.
Quality Engineer ensuring quality of iOS features from design to release at Adobe. Collaborate across teams to validate workflows and improve product quality.
Advanced Quality Engineer ensuring quality requirements in automotive seat production for Mercedes. Collaborating with internal teams and external suppliers during product development and program launch.
Supervising QA associates in PCI Pharma Services ensuring compliance with regulatory standards and effective quality management. Managing external audits and collaborating with production and customer service teams.
Staff Software DQA Engineer leading quality assurance for partner management and integration. Ensuring compliance and interoperability for digital health products at Insulet Corporation.
Senior Design Assurance Engineer ensuring quality and compliance in medical device product development. Collaborating with cross - functional teams on embedded software systems and regulatory requirements.