Quality Lead

3 months ago

Cramlington, United Kingdom Organon Full time

Organon in Cramlington, UK are recruiting a Quality Manager to lead the relevant Quality Function (Bulk or Pack), including a Team of QA Specialists.

**Responsibilities**:

- ** Providing Quality Oversight on all production activities and ensure that either: all products manufactured at Cramlington and UK Tollers are manufactured, assembled and analysed in accordance with regulatory guidelines to meet both internal and external customer demands.**:

- ** Providing strong quality leadership to the Cramlington site, particularly with respect to investigation of deviations occurrences and continuous improvement of compliance culture.**:

- ** Leading the Quality Operations team and managing the interaction with the production teams.**:

- ** Partnering with the production lead to sponsor and lead quality improvement projects within the Site HOSHIN, Quality Operations and the production **portfolio.**:

- ** Partner with operations to drive a culture of Built in Quality and Right First Time where everyone is a Quality and Compliance Leader.**:

- ** Attend Quality Review Council and support the Quality Compliance Plan.**:

- ** Participate in Quality Walk throughs, cGMP Audits and Regulatory Inspections**:

- ** Conduct supplier audits as required and participate in the internal audit programme in support of the site auditor and permanent inspection readiness.**:

- ** Quality Oversight of sub-systems and ensure site procedures and practices are in compliance with Regulatory requirements.**:
**Requirements**:

- ** Experience in the pharmaceutical industry.**:

- ** Good written and spoken communication skills and ability to work in and lead cross-functional teams.**:

- ** Ability to form good working relationships with other functional groups.**:

- ** Attention to detail and well-organised approach to working.**:

- ** University degree in Chemistry, Pharmacy or other scientific or statistical discipline or equivalent.**:

- ** Strong Continuous Improvement mindset with experience and skills in the tools.**:

- ** QP qualification desirable but not essential.**:
**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.

**Search Firm Representatives Please Read Carefully**

**Annualized Salary Range**

**Annualized Salary Range (Global)**

**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**

10%

**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Number of Openings**:
1
**Requisition ID**:R522675

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