Regulatory Information Management Systems Business Quality Manager

Job Title: Regulatory Information Management Systems Business Quality Manager

Global Career Level: E

Introduction to role

The RIMS Business Quality Manager is a pivotal leadership position within the Regulatory Technology & Operational Excellence (RTE) unit at AstraZeneca. This role is crucial for system ownership and business tool management ensuring that the systems managed by FTE are fully compliant with GxP requirements arising from the regulated business processes they support. The individual will provide Quality Management oversight across Regulatorys systems ensuring that all validation documents are clear complete retrievable and that the systems meet applicable GxP requirements.

RTE as part of Regulatory is accountable for the effective governance maintenance and enhancement of RIM systems owned by Regulatory and for delivering expert services in support of their use by the business. RTE ensure that the companys pharmacovigilance regulatory and legal obligations in respect of these systems can be fully met. The groups remit encompasses the following systems:

• Regulatory Knowledge Systems (Labelling Veeva RIM (including Content Management Publishing Registration/Tracking Data Health Authority Forms Planning tools

• Pharmacovigilance Systems

• Safety Surveillance Systems

The majority of these systems support regulated business processes and are maintained in a validated state against mandatory standards both internal and external. Of particular importance here are Veeva RIM the Companys businesswide system for the management of Regulatory Knowledge (Regulatory Product Knowledge and Regulatory Status Information) the Companys global safety database and reporting system. Veeva RIM is an enterprisewide and businesscritical one driven by electronic records legislation GxP and submission technical standards (e.g. eCTD and EVMPD) the other by pharmacovigilance legislation (GVP) and ICH E2B standards. Whilst these two systems are arguably the two most critical they are merely given as contrasting examples of the different legislative drivers and governing standards.

Accountabilities

• Responsible for ensuring that GxP regulatory compliance requirements on Regulatoryowned computerised systems that support GxP regulated business processes are understood and met.

• Responsible for Quality Management oversight of computerised systems owned by Regulatory 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 Regulatoryowned 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 GRASPQA system estate from a QM perspective as well as a rolling highlevel view of system change.

• Approval of the Regulatory Impact Determination (RID) for all GRASPQAowned 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 GRASPQAowned 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 highlevel risk assessment process to ensure that risks relating to GxP impact are included and managed.

• Review and approval of the Validation Plan for all GRASPQAowned systems ensuring the activities planned are appropriate to address the GxP requirements. Approval of the User Acceptance testing.

• Responsible for signing off all GRASPQAowned 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 GRAPSQAowned systems by working closely with the business and IS 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 IS 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.

Essential Skills/Experience

• Bachelors 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 computerised 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 organisational skills.

Desirable Skills/Experience

• 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 sciencerelated 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 problemsolving skills

• Strong focus on quality

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products we work in areas of unmet need and take innovative regulatory approaches to bring lifechanging treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. Innovative problemsolvers we deliver rapid and global approvals transforming breakthrough science into tangible value and turning meaningful innovation into lifealtering solutions. Be trusted and empowered to be the best you can be. Here we thrive in our inclusive diverse and bold environment. We draw on our diverse knowledge to take smart risks and uncover new and creative ways to deliver better for our patients and our business.

Ready to make a difference Apply now!

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 industryleading 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 nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.