Organon
**Job Description**:
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
Under the leadership and directional guidance of the Director, Audits & Inspections who drives and supports the development and implementation of strategies and initiatives to maintain and advance the Research & Development (R&D;) Quality Management System (QMS), the Associate Director will support activities related to audits and health authority inspections for the various R&D; functions related GXPs and will partner with cross-functional Leads to ensure the achievement of quality goals. Assignments are complex and require detailed understanding of regulations and processes to minimize and mitigate risks.
**Primary Activities**:
**Primary skills include but are not limited to**:
**Collaboration and Partnering**: Demonstrates advanced ability to work in partnership with others within the Company and external partners to accomplish quality goals; possesses advanced leadership skills.
**Communication Skills**: Demonstrates advanced communications skills to convey and receive information. Demonstrates advanced oral and written communications skills.
**Problem Solving**: Demonstrates expert level skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction.
**Strategic Thinking**: Demonstrates advanced skills to drive change that enhances processes within quality or across areas within R&D; that improve quality and /or add value to the business.
**Project Management**: Demonstrates expert 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 advanced 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 advanced level of knowledge of regulations and business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs.
**Regulatory and Compliance Management**: Demonstrates advanced knowledge of regulations and regulatory trends to ensure the functional areas within R&D; are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.
**Educations/Experience**:
BS/BA degree in relevant field (Pharma/Science/Engineering) area with
– Minimum of 10 years prior experience in the Pharmaceutical/Biotechnology industry with a thorough knowledge of Quality Systems, Quality Assurance and Quality Control including solid knowledge of global GXP Quality and regulatory requirements.
– English: Advanced Level
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
**Who we are**
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.
Our Vision is clear**:A better and healthier every day for every woman.**
At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion. At
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