Sr. Specialist Commercial Manufacturing QA

SUMMARY
The Senior Specialist, Commercial Manufacturing QA is responsible for the Quality oversight of commercial manufacturing activities associated with Drug substance and Drug Product.

He/She ensures compliance of assigned registered products throughout their lifecycle, with cGMP requirements and registration files.

He/She is responsible of assigned product quality management.

DUTIES AND RESPONSABILITIES

• Act as the QA expert for assigned biological products.
• Manage the day-to-day quality oversight of assigned Commercial CMOs including compliance and performance monitoring.
• Assures compliance of products by creating, approving and maintaining Product monographs.
• Perform Batch Record Reviews and decide on batch dispositions.
• Maintain and Control the Product Batch records filling and databases.
• Manage and approve internal and external deviations, OOS and related investigations.
• Manage and monitor implementation of internal and external change controls.
• Manage and monitor implementation of internal and external CAPAs.
• Coordinate the collection of APQR data and lead the issuance of Incyte Annual Product Quality Reviews.
• Maintain Quality and Technical Agreements with assigned Commercial CMOs.
• Contribute to the maintenance of Incyte Quality Management System with a focus on the biological related SOP.
• Perform external and internal audits according to Incyte audit program.
• Support the RA-CMC group for regulatory submissions and follow-ups.
• Ensure inspection readiness at assigned Commercial CMOs.
• Interpret GMP, general regulatory requirements and Quality systems regulations in the area of manufacturing and ensure implementation as applicable.
• Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
• Stay current with the applicable regulations and promote Quality across the Incyte organization.
• Cooperate with the Commercial Supply Chain, RA-CMC, Analytical and Manufacturing operations and Regulatory Affairs functions in matters relating to Commercial Products.

REQUIREMENTS

• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering),
• Firsthand experience of min 5 years in Quality Operations for pharmaceuticals,
• Expertise in Biotechnology products,
• Experience in Contractors Quality oversight,
• Thorough knowledge in cGMP and US regulatory requirements,
• Demonstrated ability to write technical documents such as APQR
• Strong Interpersonal skills ;
• Strong verbal and written communication skills with well-structured communication and presentation ability ;
• Ability to manage multiple on-going projects ;
• Results focused which may require negotiating skills, empathy, diplomacy, common sense
• English fluency written and spoken (the company language) ;
• Travel, up to 20%.
  

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.

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