Overview
Temporary position
SUMMARY
The Senior Specialist Global Distribution QA is a key contributor to the expansion of Incyte products in multiple markets. He/she ultimately ensures that commercial products are distributed to end-customers in compliance with Incyte Quality standards and applicable regulations and GxP guidelines.
He/She manages the preparation, submission, approval and maintenance of GMP applications and oversees the Incyte distribution network in the assigned region.
DUTIES AND RESPONSABILITIES
* Contribute to submission preparation activities with Incyte QA and Incyte CMOs.
* Perform initial gap assessment for QA documentation in preparation of GMP applications.
* Collect and maintain product submission data as well as country specific GMP accreditations for Incyte entities and partners.
* Support and closely collaborate with Incyte Regulatory affairs for MAAs activities from initial submission up to products approval and variations submissions.
* Collaborate with Incyte commercial partners for submissions management.
* Coordinate submissions preparations activities with Incyte QA manufacturing and Incyte CMOs.
* Support the global distribution QA department in maintaining and improving the GMP applications process and its related dashboards.
* Update Quality Agreements in line with the expansion plans.
* Ensure qualification status of distribution partners in new markets.
* Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
* Stay current with the applicable International Regulations and promote Quality across the Incyte organization.
* Contribute positively to a strong culture of business integrity and ethics.
* Act within compliance and legal requirements as well as within company guidelines.
REQUIREMENTS
* Academic degree in natural or applied sciences preferred.
* Relevant experience in the pharmaceutical and/or biotech industry preferably in Quality related roles and in market readiness activities.
* Thorough knowledge in cGMP and GDP and global regulatory requirements.
* Strong interpersonal skills.
* Excellent verbal and written communication skills.
* Proficiency in English.
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