Beschreibung
Role Purpose:As an Operations Quality Senior Quality Partner you are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other. You are responsible for building and developing your capabilities to contribute more to the team, customers and patients. You apply new approaches to improving your work to increase productivity, reduce costs or mitigate significant compliance issues within your area of influence. You work as a strategic business partner to help break down silos between organizations (internal and external) all which lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle. You push the boundaries to enable and implement smart, risk-based compliant processes that result in quick and efficient innovation.
Aufgaben:
- Drive business results and customer value
- Performing activities as required to meet Q&R goals and objectives independently and being able to identify improvements and implement with collaboration from your manager.
- Document authoring and review as required to support changes. Performs technical reviews, as applicable. May require collaboration with supervisor on technically complex technical reviews independently.
- Preparing documentation for and participating in audits as applicable.
- Responsible for training, coaching and mentoring other quality managers or business partners, as applicable in a professional manner to ensure that business needs are being met.
- Able to troubleshoot issues as they arise, develop and independently implement solutions to ensure that daily work is completed without jeopardizing compliance.
- Communicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management
- Advance the work of the Network, making tradeoffs and breaking silos
- Complete daily scheduled and unscheduled activities, initiate activities independently and interactions across departments as applicable.
- Identify, Initiate, facilitate, participate and implement process improvements to meet business needs. Able to link responsibilities with both site and Global Quality and Regulatory and drive innovation across the local organization/site.
- Participates in large/global cross-functional or cross-chapter projects.
- Be involved in solving unique or unprecedented problems that have an impact on a part of the organization, function or chapter.
- Empower and enable the Network
- Build and maintain strong partnerships with colleagues and business patterns to assure alignment around strategic projects and day-to-day activities and to assure mutually successful working relationships.
- Enable the organization's New Ways of Working
- Model behaviors to support the organization's transformation to new, more Agile Ways of Working - e.g. new decision making/governance practices, collaboration, etc.
Your Profile:
- Completed Master's degree in natural sciences (e.g. chemistry, biotechnology or pharmacy); alternatively a completed Bachelor's degree in natural sciences with professional experience in a comparable field
- Profound work experience in the GMP environment, ideally in quality assurance and/or quality control in dia- and/or pharmaceutical sector
- Good knowledge of analytical and method development/validation as well as process and method transfer
- Good knowledge of cleaning processes
- Experience in the preparation of process risk analyses and good process understanding
- Ensure implementation of regulatory requirements and review of above validation documents and inspection and test plans
- Experience in the creation or evaluation of process risk analyses
- Knowledge of deviation management and change control
- Very good English skills (for meetings and documentation)
- Good knowledge of MS Office and Google applications (e.g. G Suite)
- Ability to work in a team and experience in agile working
Dieser Geschäftszweig der SThree GmbH betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.