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Organon is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a Senior Quality Assurance Specialist, you will be responsible for ensuring quality and compliance with local and international regulatory requirements by conducting internal and external audits.
Key Responsibilities- Evaluate Organon systems, processes, affiliates, vendors, business partners, and investigator sites for compliance with regulatory requirements.
- Schedule and conduct GVP/GCP 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 with limited guidance.
- Conduct meetings with senior management to discuss audit observations and responses.
- Supports the implementation and maintenance of the GVP/GCP risk-based strategy, including development of the annual audit plan.
- Responsible to ensure audit tracking tools are up to date.
- Participate in regulatory inspections and external audits, when required.
- Review and provide input into the quality sections of the Pharmacovigilance System Master File (PSMF).
- Maintain a high degree of knowledge of global industry expectations and GVP/GCP regulations.
- Train and mentor junior team members.
- Bachelor's degree in a relevant field (pharmacy, life sciences, etc.).
- Fluency in written and spoken English, additional language skills a plus.
- Minimum of five (5) years of experience in the pharmaceutical industry.
- Minimum of one (1) year of experience in GVP/GVP auditing with EU/FDA/global regulatory requirements.
- Strong knowledge of EMA, FDA, and ICH guidelines.
- Attention to detail and ability to work independently.
- Collaboration and partnering: demonstrates ability to work in partnership with others within the company and external partners to accomplish quality goals; possesses advanced leadership skills.
- Communication skills: strong verbal skills and experienced effective writing skills.
- Project management: 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.
- Decision making: demonstrates skills to utilize knowledge, networks, and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.
- Business operations/knowledge of field: demonstrates knowledge of regulations, regulatory, and business trends and applies this knowledge to optimize daily activities and ensure the functional areas within R&D are compliant with regulations and appropriate procedures.
