Title: Associate Director, Pharmacovigilance Quality
Location: Raleigh, NC or Remote
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
The Associate Director, Pharmacovigilance Quality, reports directly to the VP of R&D Quality. He/she is responsible for supporting GVP activities performed at TGTX and at our PV vendors in both the clinical and post-marketing pharmacovigilance activities.
This role provides expertise related to relevant and current GVP global regulations and guidelines, and partners with other Quality to enable transparency & escalation of R&D quality and compliance issues. The role provides risk-based rationale to enable decision-making and supports the development and execution of effective and comprehensive action plans to address quality and compliance risks as it relates to clinical safety and post-marketing Pharmacovigilance.
––Develops and evaluates relevant metrics, proactively assesses potential risks (i.e. submission compliance, trend analyses, PV vendor quality oversight) and recommends mitigating / remediating actions to functional stakeholders
––Consults on CAPA prioritization, development and execution with regards to major and critical audit or inspection findings
––Supports development and implementation of R&D Quality Management System (QMS) strategy, framework, methodology, infrastructure and tools at it relates to the development and maintenance of the PV Quality System
––Provides oversight or ownership of processes and procedures, establishing metrics and thresholds to ensure processes are achieving their goals and are in a state of quality control; will drive, execute and/or participate in process improvements
––Travels approximately 15-20% of time including visits to TGTX offices or PV vendors to support audits, inspections or other business meetings. Frequency of travel may increase for short durations in order to meet critical business needs.
– Serve as the disease area expert and providing support to cross functional team members, including onboarding and review of materials
––At least 10 years pharmaceutical or biotechnology drug development experience
––5-6 years in a quality or compliance related discipline or equivalent quality management activities, particularly with Pharmacovigilance and GVP activities
––Demonstrated experience with building a quality management system or equivalent cross-functional project/system
––Must be flexible and comfortable with a risk-based approach to quality
• Willingness and ability to travel domestically and internationally, as required.
BS/BA, MS; Bachelor’s degree required, Masters in Biology/Chemistry, Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred