Manager, Quality Technology, R&D Quality Assurance

Location: Warsaw, Poland
Hybrid model of work: 3 days in office, 2 remote per week
 

As the independent second line assurance function for R&D, our mission in R&D Quality Assurance (QA) is to achieve enduring excellence in auditing, quality management, quality risk assessment and enhance the R&D quality mindset for the benefit of our patients.

The Quality Technology Manager manages technical and logistical services in compliance with document and system standards within the QAs remit. The role holder contributes to the implementation and conduct maintenance activities of

systems, platforms and processes and in addition acts as a point of contact and support related to these systems.

Typical Accountabilities

In close collaboration with QA Associate Director and Directors, depending on system:

• Conducts maintenance activities
• Provides metrics and creates reports
• Conducts system testing by e.g User Acceptance Testing or Business Quality Manager Testing: contributing as BQM and leading BQM Group
• Conducts data checks
• Manages Helpdesk Queries by responding to queries from the end users
• Interacts and collaborates with the QA Business Process Owners (BPO) to achieve a good working practice related to the use of the system and procedural documents
• Interacts and collaborates with other key Stakeholders in the business, to achieve a good understanding and working practices and user requirements
• Manages approval and termination of User Accounts
• Supports training and onboarding
• Supports development or coordinates communication and training material
• Supports inspections

Quality Assurance General Accountabilities

• Ensures own tasks are performed to current practices and in accordance with company policies, standards, SOPs and other relevant instructions
• Promotes a culture of ethics, integrity and continuous improvement that focuses on delivering efficiencies and planned business benefits
• Communicates effectively with QA colleagues and business stakeholders
• Leads training for colleagues and business stakeholders as required
• Involved in and may lead the development and/or revision of QA processes, projects and tools
• Mentors QA colleagues
• Provides general support related to regulatory authority inspections as and when required

Essential

• Degree level education
• Experience in pharmaceuticals or a related industry
• Excellent analytical, written and oral communications skills
• Proven expertise in system administration and information management
• Experience in pharmaceuticals or a related industry and a good understanding for business processes within area of accountability
• Fluent in written and spoken English
• High ethical standards, trustworthy, operating with absolute discretion
• Strong collaborative, influencing and interpersonal skills – curious to understand business environment
• Skilled at managing & using technology
• Ability to maintain and create professional networks with stakeholders

Desirable

• Project management
• Document Management

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.