Business Quality Manager, Associate Director Patient Safety Technical Solutions

Job Title: Business Quality Manager, Associate Director Patient Safety Technical Solutions

Global Career Level: E

Introduction to role

Join our dedicated Oncology team and play a pivotal role in ensuring the compliance and quality of our Patient Safety Systems (PV Systems). As part of Patient Safety Surveillance, Analytics, and Systems (PSSAS), you will be responsible for the governance, maintenance, and enhancement of systems owned by the Patient Safety Center of Excellence (PS CoE). These systems are critical to meeting our pharmacovigilance, regulatory, and legal obligations. Your expertise will ensure that our systems, including Pharmacovigilance Systems (Business Objects, ARGUS), Safety Surveillance Systems (ARIADNE, TAS, NGSMS), and others (BRAT, RMP Tracker), are maintained in a validated state against mandatory standards.

Accountabilities

• Ensure GxP regulatory compliance requirements on PS CoE-owned computerized systems that support GxP regulated business processes are understood and met.

• Provide Quality Management oversight of computerized systems owned by PS CoE, ensuring GxP requirements are considered, and validation documents are clear, complete, and retrievable.

• Offer Quality Management expertise to ensure PS CoE-owned systems meet all relevant GxP requirements and quality standards.

• Maintain an overview of the PS CoE system estate from a QM perspective and a high-level view of system changes.

• Approve the Regulatory Impact Determination (RID) for all PS CoE-owned systems and participate in Privacy Impact Assessment and eDiscovery assessment as part of the RID.

• Review and approve User Requirements Specification for all PS CoE-owned systems, ensuring GxP-related requirements are included and clearly identified.

• Provide input to the high-level risk assessment process to manage GxP impact risks.

• Review and approve the Validation Plan for all PS CoE-owned systems and sign off systems into use via approval of the Validation Report.

• Participate in project audits, quality management reviews, and inspections as necessary.

• Contribute to the overall quality of PS CoE-owned systems by collaborating with business and R&D IT teams.

• Ensure system quality through early deviation detection and risk reduction.

• Maintain up-to-date knowledge of regulations pertaining to computer system validation with an emphasis on GxP processes.

• Work closely with R&D IT Quality Manager and Business Project Manager to understand potential GxP impacts.

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 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.

Desirable Skills/Experience

• Ability to proactively identify potential compliance issues and advise on their avoidance/resolution/remediation.

• In-depth knowledge of current developments in the pharmaceutical industry and global regulatory environment.

• Experience 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 follow the science and pioneer new frontiers. Our Oncology team is dedicated to eliminating cancer as a cause of death. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. We fuse cutting-edge science with the latest technology to achieve breakthroughs. Backed by investment, we aim to deliver six new molecular entities by 2025. Our environment is built on courage, curiosity, and collaboration. We make bold decisions driven by patient outcomes. Empowered to lead at every level, we take smart risks that write the next chapter for our pipeline and Oncology team. Join us to build a rewarding career as part of a team committed to improving the lives of millions with cancer.

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.