About the role

Associate Director responsible for pharmacovigilance quality assurance audits and compliance. Leading audit programs ensuring adherence to regulations and supporting teams in various projects.

Responsibilities

Schedule and conduct assigned PV audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.
Prepare audit reports and manage follow-up activities within established timelines.
Maintain broad-based expertise in Organon Policies, Procedures and Guidelines, local and global regulatory requirements, etc., pertinent to GVP.
Maintain awareness of evolving industry and regulatory trends/regulations.
Obtain and maintain cutting-edge knowledge, and application, for various Quality auditing topics.
Generate and present comprehensive presentations/summary of audit issues for effective communication to all levels, as needed.
Leads initiatives / drive results in various projects, as assigned, to maintain the effectiveness and efficiency of the audit program, and to ensure the audit program continues to meet company and regulatory expectations.
Supports the implementation and maintenance of the PV risk-based strategy, including assistance in the development of the annual audit plan and maintenance of the audit tool.
Reviews and provides input into the quality sections of the Pharmacovigilance System Master File (PSMF).
Supports regulatory inspections and external audits, when required.
Train and mentor junior team members.

A minimum of a Bachelor’s degree in a relevant scientific field (Pharmacy, Life Sciences, etc.)
Fluency in written and spoken English; additional language skills a plus.
Minimum of ten (10) years of experience in the pharmaceutical industry or regulatory agency related to Quality Systems and Quality Assurance (e.g., clinical trial quality, pharmacovigilance, regulatory).
Minimum of one (1) year of experience in PV auditing with EU/FDA /global regulatory requirements.
Strong knowledge of EMA, FDA and ICH guidelines in GVP and proficiency in interpreting and applying regulatory requirements and guidelines.
Attention to detail and ability to work independently in a virtual environment.
Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook).
Availability to travel up to 20% of time.
Demonstrates ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.
Strong verbal skills and experienced effective writing skills.
Demonstrates ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
Demonstrates skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.
Demonstrates knowledge of regulations.