Head, PV and Regulatory QA
CSL
full-time
Posted on:
Location Type: Hybrid
Location: Maidenhead • Massachusetts • United States
Visit company websiteExplore more
Job Level
Tech Stack
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilanceQuality AssuranceGVP regulationsGCP regulationsDeviation managementCAPA managementclinical researchaudit strategyperformance reportingbudget development
Soft Skills
leadershipcommunicationnegotiationinfluencingorganizational skillscustomer serviceanalytical skillsdecision-makingcross-functional collaborationstrategic assessment