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Global Product Quality Steward - Solid Dose - Switzerland
Posted on : 26 December 2016
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.
PURPOSE AND SCOPE OF POSITION:
- 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.
DUTIES AND RESPONSIBILITIES:
- 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