The QRM (Quality Relationship Manager) is a member of the US Quality department. In this position, the QRM will be interacting primarily with external business partners/CMOs. The incumbent will have responsibility for oversight of multiple complex sterile products and medical devices throughout…
The QRM (Quality Relationship Manager) is a member of the US Quality department. In this position, the QRM will be interacting primarily with external business partners/CMOs. The incumbent will have responsibility for oversight of multiple complex sterile products and medical devices throughout the entire life cycle of the product (i.e. from development through discontinuation) and is responsible for supporting the adherence to the company's Quality Management System. The position will require in depth knowledge of Quality Systems including activities such as validation, troubleshooting/ investigation support, complaint handling, change control, product release, inspection support, etc. The individual will also support the technical transfer of products to/from various CMO’s. The individual serves as a critical link to external partners. Being able to effectively communicate and transmit information to/from the partners is essential to ensure compliance and optimal performance.
1) BS in Pharmacy, Chemistry, Microbiology or Biology with a minimum of 10 years’ experience in the Pharmaceutical Industry preferred, with a minimum of five years in a quality organization. Other degrees will be considered based on extensive industry experience.
2) Experience in GxP laboratory practices, ability to review and assess data.
3) Release of materials and products supporting both development and commercial activities.
4) Has knowledge of GxP quality systems, US FDA regulations, USP and ICH guidance documents. Knowledge of EudraLex a plus.
5) Experience with various complex manufacturing / filling processes associated with ’sterile’ drug products and medical devices.
6) Experience in trouble-shooting and conducting investigations.
7) Must hold strong interpersonal and communication skills. Must have the ability to work well with diverse groups including the ability to work in a team environment. Must also display strong organizational skills with the ability to lead team meetings and to manage multiple projects at one time.
This role is being handled by Olivia at Meet, full details are available upon application and you can contact Olivia Fico on email – firstname.lastname@example.org or reach her on the phone at Meet HQ on 646 822 2197.