Quality Systems Integration and
il y a 3 jours
To further strengthen our Quality team, we are looking for an experienced and motivated Quality Systems Integration and (Business) Administration Manager to drive right first time and future proofed implementation and integration activities related to the our global quality systems. The Quality Systems Integration and (Business) Administration Manager will be a member of the Comp ut er Systems Quality team and key business partner with our Business Information Systems Group and Implementation partners.
This position reports to:
Computer Systems Quality Lead
**Key Accountabilities and Responsibilities**:
- Provide strategic direction for electronic quality system setup and configuration
- Provide support for the selection, implementation and maintenance of future ready quality systems
- Ensure ongoing improvement of the Quality Systems to meet the requirements across the business
- Support post implementation integration activities for Quality System s across the business
- Manage direct day-to-day GxP quality system operations and business administration support : Performing routine activities maintaining picklist & objects, include foundation information, templates and user requests
- S upport Business owners providing support to the end-users Responsible for business administration activities to support Quality Systems and business activities
- Provide monitoring and management of the systems ( eg. via reports/dashboards)
- Support in new releases as business admin
- Partner with the integration teams to review progress and resolve roadblocks, escalating issues and/or implementing recovery plans as needed
- Monitor feedback from stakeholders / customers to continuously improve the electronic Quality System s Integration, framework and standard work
- Drive global continuous improvement initiatives of our Computer Q uality S ystems
- Support delivery of the Global Audit Program s
- H ost Regulatory Authority and business p artner inspection and audits
- U ndertake ad hoc quality tasks as relevant to support the global quality organization.
**Desired Skills and Experiences**:
- BS in technical disciplines involving engineering or quality required ( ie. Computer Science)
- Proven success in implementing quality systems in pharma setting
- 5 y+ experience with integration of quality systems and follow up monitoring
- Experience with audits related to quality systems
- In-depth knowledge of FDA, PMDA, EU regulations and ICH Guidelines
- Proven l eadership and communication skills, with the ability to influence individuals at all levels
- V ersatile and flexible working style
- A ble to independently manage projects and make sound decisions related to quality systems
- Strong technical mastery in quality systems, analytical and investigation skills
- Proven ability to collaborate effectively with stakeholders from different Functional Areas a s a strong team player
- Able to work effectively together with both internal and external stakeholders
- Able to operate in a dynamic, fast growing biotech company with challenging timelines
- Able to p r omote quality culture at all level s within the company
- E xcellent verbal and written communication skills
- Fluent in English, our working language.
**Offer**:
- A competitive salary package with extensive benefits
- Front seat in the development of therapeutic antibodies
- A work environment in a human-sized, dynamic and rapidly growing biotech company
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