Beschreibung
Hi,I'm looking for a Quality Assurance System Manager
to be based onsite mainly in Zurich, Switzerland - some travel to Germany can be required
Start: September year contract + extention possible
Description:
OBJECTIVES/PURPOSE
- This role is responsible for maintaining Quality governance, processes and improving overall site capability.
- This includes oversight and sustainability of the Global Quality Management System as well as adherence to any supplemental local requirements.
ACCOUNTABILITIES
• Q-Council & KPIs: consolidation and support to the Region.
• Follow-up of Data Integrity projects
• Follow-up of Compliance Projects such as, but not limited to: implementation of GSOPs, Continuos Process verification, Inspection Readiness and Site related projects.
• Active collaboration and support in the management of Critical Events.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise :
(Breadth and depth of knowledge, application and complexity of technical knowledge)
• Knowledge and experience in Pharmaceutical industry (GMP environment), at a manufacturing site whenever possible.
• Knowledge and understanding of relevant regulations enabling effective performance of accountabiliies mentioned
• Knowledge and understanding of global and local Quality and Regulatory concepts and requirements (e.g. GMP, ICH, Annex 1, Compendia, etc.)
Leadership :
• Ability to influence and coordinate different activities and projects accross the sites network.
• Ability to act locally as well as engaging to support global activities
Decision-making and Autonomy :
• An active member of Operating Unit / Regional Quality Leadership teams.
• Responsible for active and timely Incident notifications and associated escalation activities
Interaction :
• Key interactions with all Manufacturing and Quality regional and operating unit teams
• Key interface with Global and Site based Quality units
Innovation :
• A firm grasp of industry, scientific and regulatory trends, understanding market conditions and leverages innovation to evolve client to become a model for industry
Complexity :
• This role reports globally but engages locally to drive significant progress and sustainable performance of the One QMS in support of both global and local prodcuts.
• The output of this role needs to be appropriately applied to all stages of the product lifecycle.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
• Scientific or engineering graduate (BSc, MSc, PhD)
• Quality assurance experience background
• 5+ years of managerial experience and responsibility in quality management at pharmaceutical manufacturing sites
• Experience must include successful examples of managing change by influence – without direct resource control;
• Experience in global pharmaceutical operations, supply chain management, Quality, project management and global environment
• Strong focus on delivering global results as well as building site capability to demonstrate effective governance
• Global pharmaceutical industry knowledge
• Fluent in written and spoken English.
Please apply via: