Global Product Quality Steward - Solid Dose - Switzerland
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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.
- 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