Director Quality

**Purpose of the Role**:
As the **Director of Quality Product Leader Women's Health** you will report to the Associate Vice President (AVP) Internal manufacturing quality and you will provide end to end product quality oversight for the women health franchise. You will support and drive innovative compliance and manufacturing excellence throughout the commercial life-size of the franchise as part of an integrated supply team. You will partner with the integrated commercial supply team (IDST)/global value chain management team (VCMT) to drive continuous improvement activities and holistic risk management specific to the franchise/products.

You will also represent the AVP Internal Manufactured Quality on key improvement initiatives within Internal Manufacturing and across the company, as appropriate.

In this individual contributor position you will work independently with all levels of the organisation, across divisions and on a global basis you will have the decisions on product quality and franchise quality. The amount of travel in this role will be around 10 to 20% of the time

**Role Responsibilities**
- Provide support and direction to ensure continuous compliant supply across nodes and to resolve testing and release issues
- Support and direct Significant Investigations (SI) and understand franchise/product risks and impact due to significant investigations, and contribute to fact finding meetings
- Partner with the Analytical Product Steward and provide support/sponsorship when required for analytical initiatives like method and compendial updates
- Partner with the Technical Product Stewart and provide support/sponsorship when required for technical initiatives
- Support and lead continuous improvement initiatives include value stream mapping, Kaizen events etc
- Partner with technical product suit provided list review of the annual product review (AQR)
- Provide input and reviews for change controls and support their prioritisation
- Complaints partner with Technical Product Steward to provide holistic review

**Your Profile**
- Bachelor's or Master's degree in chemistry, pharmacy, biology, microbiology, chemical engineering (or equivalent)
- At least 10 years of experience in the Pharmaceutical industry, with solid knowledge of global GMPS and global regulatory requirements
- Expertise and broad experience in Quality and Manufacturing and in product development and registration including solid knowledge of global GMP and regularity requirements experience in Women's Health franchise preferred
- Excellent project management and organisation skills and strong demonstrated interpersonal, communication, collaborative and leadership skills in dealing with a broad variety of cultures
- Demonstrate ability manage across a broad framework of initiatives and influence employees across all levels and all functions and ability to create simplicity out of complex environments
- Strong demonstrate community skills by verbally as well as well as writing in English

**Welcome to our team**:
Our quality organisation ensures every single material that comprise our products are manufactured, processed, tested, packaged, stored and distributed aligned with our high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, we create an interdependent global manufacturing network dedicated to deliver a compliant, and reliable supply to customers and patients on time, every time, across the globe.

**Secondary Job Description**

**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.

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**Annualized Salary Range**

**Annualized Salary Range (Global)**

**Annualized Salary Range (Canada)**

**Please Note: Pay ranges are specific to local market and therefore vary from country to country.**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
No

**Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites**

25%

**Flexible Work Arrangements**:
Remote Work

**Shift**:
**Valid Driving License**:
Yes

**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R529745