QA Advisor

**Job Title: QA Advisor - Global Business Services**:
**Career level - C**

**Introduction to role**

AstraZeneca (AZ) has a bold aspiration to improve the lives of 200 million patients by delivering 20 new medicines by 2030. This role is critical in contributing to AZ’s long-term ambition. Global Business Services (GBS) is growing to support critical functions across the whole enterprise. This role will be specifically focused on defining and delivering GBS opportunities within the R&D areas of the business. GBS is enhancing its customer focus by establishing Research & Development (R&D) Services to improve alignment and strengthen our relationships with SET areas. R&D Services is a key element of the GBS Bold Ambition, driving our vision to enable AstraZeneca to change and grow at speed. Between now and 2030, 10 new R&D capabilities are to be established, ensuring that GBS can offer the broad range of services required to support AZ ambitions.

**Accountabilities**:

- Support the efficient processing and reporting of adverse event cases within regulatory timelines
- Implement and maintain standardised operating procedures (SOPs) for case intake and processing, ensuring consistency with global pharmacovigilance practices
- Support with the preparation, review, and approval of quality-related documentation, including SOPs, batch records, and validation protocols, ensuring accuracy and compliance
- Work with tools to monitor compliance, quality metrics, and key performance indicators (KPIs) for global PV processes, license partners, and vendors. Ensure feedback and trend analysis to support AstraZeneca continuous improvement.
- Support internal assessments, external audits, and regulatory inspections, and drive best practices for audit and inspection management in collaboration with the client’s Quality Assurance teams.
- Lead investigations into quality issues, deviations, and non-conformances, determining root-cause and implementing Corrective and Preventative Actions
- Respond to Corrective & Preventive Actions and deviation processes, provide support and guidance on development and implementation, track progress, collect evidence, and coordinate effectiveness checks.
- Proactively support internal training programs related to audit/inspection readiness, compliance, and quality performance indicators, ensuring alignment across global PV teams and affiliates.
- Support data governance initiatives to ensure high-quality data for decision-making, assess downstream implications of data activities, and align ongoing initiatives with compliance requirements.
- Ensure compliance with global regulatory requirements, including timely submission of appropriate Regulatory Reports to relevant authorities
- Contribute to the development and optimisation of global patient safety processes, systems, and tools, including automation solutions
- Stay updated on regional and global pharmacovigilance regulations for those MCs supported by the hub, ensuring that necessary changes are implemented to maintain compliance
- Self-serve training and development of GBS quality and compliance knowledge and skills within the hub.

**Essential Skills/Experience**:

- BA or BS degree or equivalent
- Experience in the pharmaceutical, biotechnology, or related industry
- Experience in Pharmacovigilance, data management, and adverse event reporting and processing, with proficiency in relevant software tools
- Strong background in Pharmacovigilance, Regulatory Affairs, or Safety Quality Assurance, with expertise in quality system standards that impact multiple departments
- Knowledge of global safety regulations for both marketed and investigational products
- Exceptional attention to detail and commitment to maintaining high-quality standards in case processing and reporting
- Ability to work in a fast-paced environment, manage multiple priorities, and meet tight deadlines
- Strong analytical and problem-solving skills
- Excellent communication skills, both written and verbal, with the ability to interact effectively with internal and external stakeholders across different regions
- Ability to work in a team environment / works collaboratively

**Desirable Skills/Experience**:

- Knowledge of global and regional pharmacovigilance regulations
- Track record in managing and optimising Patient Safety processes
- Proficiency in safety databases, ideally Argus, and case management systems
- Proven experience in supporting projects within a highly matrixed, multicultural global setting, demonstrating facilitation, problem-solving, and quality and compliance resolution skills.
- Solid understanding of PV and Clinical Research processes, including their interfaces and contributions to the overall PV system.

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,