Sr. Specialist, Commercial Manufacturing QA

☞ Incyte

View: 131

Update day: 29-03-2024

Location: Morges Vaud VD

Category: Sales

Industry: Biotechnology Research

Position: Mid-Senior level

Job type: Full-time

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Job content

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
  • Manage the day-to-day quality oversight of assigned Commercial CMOs including compliance and performance monitoring,
  • Assure compliance of products by creating, approving and maintaining Product monographs,
  • Decide upon batch disposition after thorough review of batch documentation,
  • Maintain and Control the Product Batch records filling and databases,
  • Support analytical and process validation initiatives occurring during product lifecycle,
  • 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, assure QA review of data and analysis 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,
  • Perform external and internal audits according to Incyte audit program, review and approve response and assure CAPA follow-up with the concerned CMOs
  • Support the RA-CMC group for regulatory submissions and follow-ups,
  • Assure inspection readiness plan implementation at assigned Commercial CMOs, ensure availability as remote support to the CMO during inspection, provide QA input to the responses and CAPA follow-up,
  • Interpret GMP, general regulatory requirements and Quality systems regulations in the area of manufacturing and ensure implementation as applicable,
  • Perform 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,
  • In matters relating to assigned Commercial Products, ensure efficient partnership and clear communication with:
    • Commercial Supply Chain,
    • RA-CMC, Analytical and Manufacturing operations
    • GMP and GDP QA teams and Global Quality System
    • Regulatory Affairs functions.
Requirements
  • Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering),
  • Firsthand experience of min 5 years in Quality Operations for pharmaceuticals,
  • Experience in Contractors Quality oversight,
  • Thorough knowledge in cGMP and EU & 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) is a must,
  • 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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Learn more at: http://www.incyte.com/privacy-policy

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.

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 here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.
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Deadline: 13-05-2024

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