Job Number: 9318

External Description: A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Your Role:

Responsible to set up and maintain a stability / shelf-life program in a manner which is both efficient and compliant with ISO 14001, ISO 9001:2015, IPEC-PQG and relevant cGMP's. Responsible to maintain a high level of performance of required team activities which includes writing, initiating, and maintaining shelf-life protocols, studies, and maintaining shelf-life reports, receiving, and storing shelf-life samples and sending shelf-life samples out for testing to support at least four different manufacturing sites and a custom stability program. This role will oversee a team of seven employees (3 in Irvine, UK and 4 in St. Louis, MO, USA) responsible to analyse shelf-life data, assist in determination of product shelf-life and preserve this data and decisions within written reports. In addition, this team will investigate out of specification and out of trend test results and use this data to help establish product shelf-life. All deviations, investigations, CAPA and change controls will be processed through Track wise.This role will oversee the teams' safety assurance, quality assurance, program improvements and operational excellence activities, maintaining equipment validation status and maintenance levels, and training, within the Central Stability team. This role directly interacts with multiple sites and multiple teams across those sites. This role can work remotely at times but will be required to work with employees and stability chambers which are in Irvine, UK on a frequent basis. Some travel is required.

Who You Are:

• Bachelor's degree (Chemistry, Biochemistry or Biology)
• 3+ years previous experience in a GMP quality role required
• Be able to demonstrate effective leadership and managment skills
• Must understand Validation, Qualification, and be able to demonstrate effective use of problem-solving techniques
• Must have a working knowledge of how to execute an out of specification and an out of trend investigation as they pertain to testing shelf-life samples.
• Must possess advanced written and oral communication skills
• Excellent organizational and time management skills required
• 3+ years' experience in a stability or shelf-life role or an excellent understanding of the regulatory requirements of a stability / shelf-life program preferred.
• Previous proven track record of people leadership is preferred
• Strong supervisourskills with a passion for personnel development preferred
• A working knowledge of shipping and receiving non-hazardous materials is highly desired.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.

Job Requisition ID: 239252

Location: Irvine

Career Level: D - Professional (4-9 years)

Working time model: full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

Notice on Fraudulent Job Offers
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Job Segment: QA, Quality Assurance, CAPA, Biochemistry, Manager, Quality, Technology, Management, Science

Job Number: 239252

Community / Marketing Title: Supervisor Central Stability

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