Global Stability Senior Specialist

We are looking for a **Global Stability Senior Specialist **to join our team. The Global Stability team is responsible for providing oversight to assure Organons stability program is effective, compliant with worldwide regulatory expectations, efficient, and supports business objectives. In this role you provide technical expertise to Organon sites worldwide, and global oversight to groups in the planning and execution of stability processes/systems and projects with potential stability impact.
- This is a remote role where we are flexible when it comes to the location._

**Role responsibilities**:

- Supports new product introductions by preparing the registration protocol and working with impacted sites on stability aspects of the program
- Prepares and approves technical responses to regulatory agency requests on pharmaceutical products.
- Performs and provides technical direction to sites, and global oversight groups on stability impact assessments in the change control system for process and stability changes
- Designs concise stability strategies, which meet all regulatory and technical needs to support post approval changes.
- Supports cross-functional investigation teams, conducts global assessments of the stability event, formulate recommendations, share outcomes with other impacted sites, and assist in assessing the need for global CAPA.
- Ensures that all consumer or distribution related stability inquiries are supported. Assesses stability data to establish appropriate categorizations for physician samples and product distribution. Assures proposed changes to label storage statements for market supply drug substances and drug products are aligned with available stability data and regulatory expectations.
- Ensures the accuracy and integrity of complex stability projects through second person reviews and approval of projects.
- Develops and revises departmental standard operating procedures (SOPs) and guidelines.
- Reviews regulatory documents for technical accuracy and compliance with agency expectations and internal guidance
- Performs statistical analysis to support stability decision, including but not limited to - shelf life changes and prediction of future results.

**Role requirements**:

- BS/MS/PhD in Chemistry or related science in a relevant discipline
- At least 5 years’ experience in the Pharmaceutical industry.
- Requires laboratory, regulatory or relevant experience and knowledge of cGMPs
- Requires superior written and oral communications skills.
- Proficient computer skills, and business/financial knowledge
- Ability to form good working relationships with other functional groups.
- Awareness of applicable agency regulations.
- Strong continuous improvement mindset with experience and skills in the tools.
- Requires established ability to achieve high productivity and ensure customer support, independently and/or in groups/team settings, by managing multiple projects/tasks simultaneously with competing priorities.
- Requires demonstrated resourcefulness, the ability to develop and implement innovative new concepts/ideas, the ability to effectively influence and negotiate, and the ability for managing and initiating change.
- Flexible working hours to cover global reach

**About Organon**:
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

**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.

Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to t