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Job Description

GENERAL SUMMARY:

The GDP Senior Manager is responsible for executing department activities to ensure objectives and priorities are delivered in a compliant and timely manner. This role is recognized as a technical resource in the principles and application of quality assurance and GDP.

The successful applicant will perform and assist with:

• GDP operational activities e.g., deviations, change controls and CAPAs

• Completion of quality agreements

• Completion of shipping and other GDP risk assessments

• Distribution GDP partner/vendor qualification

• Distribution GDP partner/vendor metric collection and presentation

This individual will collaborate with business stakeholders and functions within the quality organization with the objective of ensuring transparency, advancing quality outcomes, and delivering on team objectives and priorities.

This role will be hybrid and some limited travel may be necessary. Office presence will be necessary 3 days/week and there may be occasions when work is required outside of regular office hours.

KEY RESPONSIBILITIES:

The position is responsible to ensure the successful execution of tasks as directed by their manager, these include but are not limited to the following:

• Manage the execution of quality processes for the distribution of Cell and Gene Therapy Commercial & Clinical Finished Goods

• Support GDP Deviations and Change Controls: manage investigations and resulting actions, ensuring eQMS records are accurate and complete.

• Support the Quality management of Cell and Gene Therapy couriers/transportation companies: creating and maintaining Quality Agreements, developing KPIs and establishing Quality meetings

• Participate in geographic expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments

• Support recalls, mock recalls, and any other in-market activity

Develop, utilize, and continue to mature tools to ensure efficiency in execution

• Support initiatives associated maintaining relevant inspection related history for inspection readiness purposes

OTHER ACTIVITIES:

• Identify areas of improvement and participate in process improvement initiatives

• Additional as needed support to processes, systems, procedures to ensure continuous quality improvement

• Additional activities as needed to support the Quality Systems/Team

• Author/revise Standard Operating Procedures and associated forms as necessary

KEY REQUIREMENTS:

• Bachelor’s Science degree or equivalent

• Quality Assurance and/or Supply Chain Quality experience in a biotech/pharma or healthcare setting

• Thorough understanding of all aspects related to GMP and GDP within Pharmaceutical distribution and supply chains

• Ability to collaborate successfully with cross-functional teams

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