Sr. Specialist / Associate Manager, Global QA Validation

☞ Incyte

View: 159

Update day: 25-04-2024

Location: Morges Vaud VD

Category: Quality Assurance / Quality Control

Industry: Biotechnology Research Hospitals Health Care Pharmaceutical Manufacturing

Position: Mid-Senior level

Job type: Full-time

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Job content

Summary

The position is responsible for supporting Global QA Manufacturing Process Validation activities associated with the introduction of new commercial product from Development to Commercial.

The role will ensure compliance and QA operational readiness of the manufacturing supply chain prior to the first commercial operations.

In addition, the role acts as the global QA center of expertize for process validation in support of commercial product lifecycle management.

Duties And Responsabilities
  • Supports all aspects of QA manufacturing associated with new commercial product introduction including technology transfers, process validation activities and over product lifecycle initiatives by:
  • Defining and overseeing for Quality Validation Programs and defining the validation strategies including initial and continuous process validation.
  • Ensuring compliance of manufacturing activities related to new commercial product introduction and throughout the product lifecycle including:
    • review and approval of process, method, validation documentation.
    • development of Product Monographs.
    • review of batch records.
    • review of manufacturing deviations.
    • disposition of product batches.
  • Supporting the qualification of new commercial CMOs and establishing Quality Agreements.
  • Supporting Inspection readiness of all new commercial CMOs.
  • Supporting product registrations by reviewing CMC sections and authoring Quality documents for regulatory fillings.
  • Performing audits according to the Global Audit Program.
  • Ensures that QMS processes, systems and procedures stay up to date with the applicable regulations as it pertains to manufacturing process validation and ensure implementation thereof.
  • Promotes a continuous improvement mindset and program across the manufacturing and QA organizations.
  • Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
Requirements
  • Science degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).
  • Firsthand experience of min 6 years in QA for international pharmaceutical and/or biotech industry.
  • Experience in managing manufacturing contractors.
  • Expertise with small molecules, biologics and various pharmaceutical forms (tablets, creams, liquids..).
  • Expertise in manufacturing process validation.
  • International exposure in positions interacting with and influencing sites operations.
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and international regulatory requirements (US, EU, JP).
  • Qualified Auditor.
  • Extensive experience in working with cross functional teams and multiple projects simultaneously.
  • Strong verbal and written communication skills with well-structured communication and presentation ability.
  • English fluency written and spoken.
  • Knowledge of other languages such as French is an asset.
  • Results focused which may require negotiating skills, empathy, diplomacy, common sense.
  • Travel up to 10%.
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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Deadline: 09-06-2024

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