Job Detail

Job Description

The person in this function leads the Global External Quality technical team in relation to daily activities. This individual will provide support in Global External Quality (GEQ) Quality Systems, Program Management, CMO processes, and Release documentation activities for all commercial and clinical products (incl. external and internal Deviations, CAPAs and Change Controls, as well as performs transactions in the IT Quality systems that are under the Quality Oversight of GEQ organization).  

Main Responsibilities:

• Manages the Global External Quality Technical Team: Ensure training of the team and development of the team members. Has accountability for the performance and results of the team and adapts team activities/responsibilities to support resource and operational challenges within GEQ as required. 


• Support the Global External Quality organization as required in the management of Quality operations and Quality system activities including system follow up of deviations, CAPAs, and change controls, as well as the Authorization to Manufacture and product Transport approvals under the responsibility of Global External Quality. 


• Leads projects, and global processes alignment (internal and external) as well as continuous improvement initiatives, regulatory intelligence actions monitoring and implementation.


• Acts as BPO for CMO Management and drives process improvements as well as global alignment and leads CMO risk forum. Responsible for revision of SOPs to reflect process & systems changes 


• Manages preparation and execution of Quality Management Reviews (global, Baar & CAM sites), Annual Product reviews.


• Act as QA contact for IT Quality systems enhancements and business processes updates as needed. Support improvements and roll out for those systems to the end users. Train end user in the use of the systems. 


• Perform resource allocation analysis for the Global External Quality organization on a monthly basis and communicate results and associates resource allocation actions (assignment of team support) to Global External Quality Leadership Team. 

Qualifications

• Min. 5 years of experience in the pharmaceutical / biotechnology industries in similar position. 


• Knowledge of cGMP requirements


• Experience in IT quality systems qualification


• Project management (lean six sigma) is a plus 


• English is a must, any additional language is beneficial 

Soft Skills

• Ability to work in an international matrix environment


• Passion for people development 


• Able to manage different tasks/projects at the same time 


• Resilient to changes

Education Minimum Bachelor's degree, Master degree preferred, in scientific field (Pharmacy, Chemistry, Biology, Biochemistry etc.)  

Additional Information

This position is an exciting opportunity if you are looking to lead an international team with complex projects. The role additionally provides support during new product market launch activities as well as leads projects from a systems perspective-  support in continuous improvement initiatives, global processes alignment, regulatory intelligence actions implementation for internal and external processes.