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 Regulatory’s 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 company’s pharmacovigilance, regulatory and legal obligations, in respect of these systems, can be fully met. The group’s 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 Company’s business-wide system for the management of Regulatory Knowledge (Regulatory Product Knowledge and Regulatory Status Information), the Company’s global safety database and reporting system. Veeva RIM is an enterprise-wide and business-critical, 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 Regulatory-owned 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 Regulatory-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 GRASPQA 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 GRASPQA-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 GRASPQA-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 GRASPQA-owned systems, ensuring the activities planned are appropriate to address the GxP requirements. Approval of the User Acceptance testing.

• Responsible for signing off all GRASPQA-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 GRAPSQA-owned 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

• 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 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 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 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 life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. Innovative problem-solvers, we deliver rapid and global approvals transforming breakthrough science into tangible value and turning meaningful innovation into life-altering 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 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.