GeneCoda has been engaged to identify and evaluate candidates for an Associate Director or Director of Pharmacovigilance Quality to ideally be located in the Research Triangle Park, NC or Northern, NJ marketplace.
About Our Client:
Our client is an innovative, commercial-stage biopharmaceutical company developing medically important pharmaceutical products in Oncology and other therapeutic areas with unmet needs.
The Associate Director or Director of Pharmacovigilance Quality is responsible for supporting GVP activities performed internally and at PV vendors in both 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 personnel 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.
- Travel approximately 15-20% of time (domestic and international); the frequency of travel may increase for a short duration to meet critical business needs.
Education: Bachelor of Science degree in a scientific discipline, technology, engineering, or related field. An advanced, post-graduate degree is desirable.
Experience and Qualifications:
- 5 or more years of experience in a quality or compliance related discipline or equivalent quality management activities, particularly with Pharmacovigilance and GVP.
- Broad quality experiences including post-marketing authorizations, pediatric, registry, EU and/or REMS studies, desired.
- Demonstrated experience with building a quality management system (QMS) or equivalent cross-functional project/system.
- Must be flexible and comfortable with a risk-based approach to quality.
- Ability to both strategize (i.e., see the ‘big picture’) and provide attention-to-detail and hands-on support.
- Ability to influence and work effectively across the entire organization from executive leadership, department, and business function heads, to cross-functional project teams.
- Strong collaborative skills. Team player mentality.
- Effective decision-making and problem-solving
- Ability to troubleshoot, identify root causes and systematically resolve problems.
- Ability to prioritize, organize and manage multiple projects simultaneously.
- Excellent interpersonal skills.
- Excellent verbal and written communication skills.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state, or local law.