Job Title - Associate Director Patient Safety Systems
Career Level - E
Join our team at AstraZeneca as an Associate Director of Patient Safety Systems within Global Patient Safety Technology Solutions. In this role, you will be responsible for the governance, maintenance, and enhancement of systems owned by Global Patient Safety (GPS). These systems are crucial for meeting our pharmacovigilance, regulatory, and legal obligations. You will ensure that our pharmacovigilance systems, safety surveillance systems, and other GPS-owned systems are effectively maintained, developed, and supported to meet business needs while adhering to all relevant regulations.
Responsible for ensuring that GxP regulatory compliance requirements on GPS-owned computerized systems that support GxP regulated business processes are understood and met.
Responsible for Quality Management oversight of computerized systems owned by GPS, ensuring the GxP requirements are taken into account, and that the necessary validation documents exist, and that they are clear, complete and retrievable.
Provision of Quality Management expertise in respect of GPS-owned systems, ensuring that they continue to meet all relevant GxP requirements, as well as all quality standards, in respect of validation documentation.
Maintains an overview of the GPS system estate, from a QM perspective, as well as a rolling ‘high-level’ view of system change.
Approval of the Regulatory Impact Determination (RID) for all GPS-owned systems, and provision of expertise into the generation of the RID, to determine whether or not a system has potential GxP impact and needs to be validated. Participation in Privacy Impact Assessment and eDiscovery assessment as part of the RID.
Review and approval of User Requirements Specification for all GPS-owned systems, ensuring that any requirements which relate to GxP, or which could impact patient safety, product quality, or records required to be created and maintained in support of GxP, are included and clearly identified as GxP within the URS.
Responsible for providing input to the high-level risk assessment process to ensure that risks relating to GxP impact are included and managed.
Review and approval of the Validation Plan for all GPS-owned systems, ensuring the activities planned are appropriate to address the GxP requirements. Approval of the User Acceptance testing.
Responsible for signing off all GPS-owned systems into use via approval of the Validation Report, which must provide sufficient evidence to support the compliance status of the system.
Participates in project audits, quality management reviews and inspections as necessary, providing an independent ‘quality’ voice.
Contributes to the overall quality of GPS-owned systems by working closely with the business and R&D IT teams responsible for maintenance and upgrade of those systems.
Ensuring overall system quality through early deviation detection and risk reduction.
Maintains a robust and ‘up to date’ knowledge of all internal and external regulations pertaining to computer system validation, with particular emphasis on GxP processes, providing appropriate recommendations for change as necessary.
Maintains a close working relationship with the R&D IT Quality Manager and Business Project Manager on each project, ensuring they fully understand the areas of potential GxP impact that each project/system may have.
Bachelor’s degree or equivalent experience within the pharmaceutical or IT industries.
Experience of computer system validation in a regulated environment, preferably the pharmaceutical industry, including familiarity with documentation such as Validation Plans, Reports, Test scripts etc., and knowledge of regulatory (GxP, SOX etc.) requirements for computerized systems and infrastructure.
Good understanding of current system development lifecycle methodologies.
Proven skills in formulating an independent and objective recommendation.
Experience of how to determine, reach and maintain acceptable quality levels.
Experience of performing, reviewing and approving risk assessments.
Clear evidence of organizational skills.
Ability to proactively identify potential compliance issues and subsequently advise on their avoidance/resolution/remediation.
In-depth knowledge of current developments in the pharmaceutical industry and global regulatory environment, and their potential impact on regulatory compliance, pharmacovigilance, signal and risk management activities, safety value demonstration and safety science-related activities.
Experience of delivering enhancement projects for a GxP, ER/ES, GVP or other ‘regulated’ system.
Key capability requirements:
Understanding and management of risk
Building relationships across cultures, functions and disciplines
Keen analytic and problem-solving skills
Strong focus on quality
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
At AstraZeneca, we thrive in an inclusive environment where curious minds come together. We are committed to making a difference by fusing data and technology with scientific innovations to achieve breakthroughs. Our collaborative approach with academia and biotech expands our horizons and empowers us to be our best.
Ready to make an impact? Apply now to join our team!
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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.