BrightOwl Loader Loading

Global Product Quality Steward - Solid Dose - Switzerland  

Celgene (company)


Posted on : 26 December 2016

Project Description

Global Quality Product Steward: Solid Dose 
  • Manager VP, Global Quality Operations 
  • Bachelor’s Degree in pharmacy, chemistry or related life sciences field. 
  • Advanced degree is preferred.
  • A minimum of 15 years related pharmaceutical experience.

  • This position provides a consistent quality oversight / approach throughout the Development Process and the Commercial Product Lifecycle. 
  • The Quality Product Steward (QPS) acquires and applies product-quality knowledge and acts as the quality expert for assigned products throughout the product lifecycle working closely with the Pharmaceutical Tech Services functions and the Commercial Operations Groups.

  • Ensures consistent quality approaches are applied across Compound Development Teams and Commercialization Teams.
  • Serves as the quality expert for the product category (i.e. solid dosage) and is responsible for making strategic quality decisions throughout the product lifecycle.
  • Provides a proactive front-end approach to product quality.
  •  Ensures quality and compliance are ingrained and built into the process during pharmaceutical development and commercial supply.
  •  Actively monitors/tracks product metrics and signals (e.g. cpk /stability, etc.) and initiates / leads improvement projects to enhance performance and /or mitigate quality or compliance risks. 
  • Provides updates of the overall Product Quality/Compliance Profile to the Quarterly Management Review Meeting.
  • Crisis Response/Action Lead in response to market metrics /quality signals / complaint trends or critical deviations. 
  • Actively gathers necessary SME’s (e.g. Technical/Regulatory) and leads team to resolve.
  • Leads/Supports multi-site/multi-function risk management programs for assigned products and tracks actions through to completion.
  • Participates in and supports complex deviation investigations, Material Review Boards, Change Management, Specification Committee, critical quality complaint resolution activities. 
  • Supports regulatory filings, inspections and compliance audits as required.
  •  Acts as the lead Quality input to ensure the Compound Development Team and Commercialization team are fully aligned around the Quality Strategy
  • Oversees the APR / PQR Process to ensure the content meets regulatory requirements and that actions arising are managed to conclusion.

Knowledge, Skills, and Abilities:
  • Must be able to critically interpret problems and effectively communicate to the GPDO Leadership Team/broader organization/across multiple functions.
  • Must be a technical/scientific expert with the ability to work with other functional SME’s to arrive at compliant/science based decisions to quality issues.
  • Demonstrated ability to effectively develop, communicate and gain support for quality action plans from a wide range of stakeholders. 
  • Hands-on knowledge of assigned product and related processes and technologies.
  • Global pharma operational experience and strong knowledge of regulatory and operating requirements in a global setting. 
  • Strong knowledge of pharmaceutical product development, clinical supply, tech transfer, and scale-up and commercial processes.
  •  Knowledge of international GMP requirements and quality systems. 
  •  Demonstrated ability to plan, organize, and drive continuous improvement initiatives in a matrix environment.
  • Direct experience of working in Pharmaceutical Development Centers/Commercial Facilities would be an advantage.
  • Ability to see the big picture and develop both short and long term action plans to ensure the companies goals are met.  
  • Known as a strong collaborator with a “can do” attitude
  •  25% travel