Supervisor, Global Sample Administration

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Supervisor, Global Sample Administration is a key supervisory role in the Global Lab Services Organization under the Analytical Services business unit. This role will be responsible to create and enforce harmonized robust processes for the overall lifecycle for samples as part of testing and projects within our global Analytical Services organization. This role will maintain DEA Power of Attorney and all processes related to the management, storage and use of controlled substances.  The Global Sample Admin team will manage both internal and external customer samples associated with global projects.  This role also includes shipping and receiving activities associated with all materials sent and received by Analytical Services and Development.

  Essential Job Functions:

• Create, execute and maintain global sample administration processes for harmonization and transparency of sample life cycle. This includes the creation of appropriate SOPs and Wis
• Supervise and maintain sample chain of custody processes to ensure compliance and efficiency
• Provide direction, oversight and development of team members within the global Sample Admin team
• Support the development of system process to automate sample and project handling
• Work closely with Project Managers and Lab Operations to provide visibility to sample disposition
• Supervise and maintain all sample records as received and stored and shipped
• Responsible for the coordination, maintenance, and final disposition of all samples received within Analytical Services and Development global lab sites through supervision of the Global Sample Admin team
• Manage and communicate the role & responsibilities of the Sample Admin team to effectively deliver sample activities in accordance with current Regulatory, GMP, business guidelines.
• Facilitate, drive and take responsibility for timely decision-making and resolution of conflicts within the Sample Admin team and raise issues to appropriate management level when needed
• Work with EHS to ensure that all samples are received, opened and stored utilizing the appropriate location and PPE
• Ensure safe practices that support the shipping of samples and materials to 3rd party vendors, customers and internal sites
• Responsible for all activity and procedures for DEA controlled substances including developing of support team, inventory and audits/inspections
• Oversee Class 10,000 ISO GMP cleanroom through documentation, procedures and direction to the Metrology team for overall maintenance
• Responsible to track all agreed KPIs and report as per agreed time schedule
• Continuously improve sample management processes and log lessons learned to share key learning and insights within the organization in support of collective knowledge bases
• Other responsibilities as assigned                                                                         

Requirements:

• Minimum of 10 years' experience in pharmaceutical or medical device industry
• Knowledge/experience of pharmaceutical product development, from concept through to product launch
• Good Pharma knowledge and experience of pharma product development from concept to submission
• Strong knowledge and awareness of GMP sample handling including DEA practices
• Cross functional team leadership experience
• Familiarity with LIMS and LMS
• Microsoft Office Suite including strong communication and presentation skills

Preferred: 

• Bachelor Degree in Science or Engineering

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