Hiring Quality Assurance Software Engineer at Extreme Networks. Work on cloud - driven networking solutions, ensuring quality through thorough testing and automated scripts in a hybrid work setting.
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
Full - stack QA Engineer responsible for coordinating testing activities and improving product quality. Involves collaboration with teams and execution of automated test strategies for software and systems.
Senior Quality Engineer defining and executing quality strategies for AI - driven products. Collaborating on data engineering and application development for product reliability and user experience.
Supplier Quality Engineer leading Preventive Quality projects and ensuring compliance with AS9145 standards at Boeing. Collaborating with suppliers and internal teams to optimize product deliverables.
Lead Engineer responsible for designing and validating test equipment and programs for power electronics. Collaborating with engineering teams to ensure high - quality product development and testing processes.
Senior Analyst ensuring audit integrity and operational excellence in pricing quality assurance at TForce Freight. Leading team reviews and driving adherence to pricing agreements and policies.
Analyst in Pricing Quality Assurance at TForce Freight maintaining audit integrity and operational accuracy across pricing initiatives. Responsible for conducting audits and providing analysis to support management.
Quality Engineer supporting product development and quality assurance at Evergen. Leading investigations, supporting supplier qualifications, and ensuring compliance with standards.
Senior Quality Engineer ensuring compliance and quality assurance for medical device design and development at Johnson & Johnson in Minnesota. Collaborating with R&D and manufacturing for effective product launches.
Quality Engineer at EDAP TMS supporting the quality management system and continuous improvement initiatives. Collaborating on projects and conducting audits to ensure quality standards are met.