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
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
Learn more at:
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .
