Software Quality Sr. Analyst - Evinova

Job Title: Software Quality Sr. Analyst - Evinova
Location: Gaithersburg, MD

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. 

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head is purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects. 

Are you ready to be part of the future of healthcare? Can you think big, be bold, and harness the power of digital and AI to tackle longstanding life sciences challenges?  Then Evinova, a global health tech business might be for you!  

Transform patients’ lives through technology, data, and innovative ways of working. You’re disruptive, decisive, and transformative. Someone excited to use technology to improve patients’ health. We’re building a new Health-tech business – Evinova, a fully-owned subsidiary of AstraZeneca Group.

Evinova delivers market-leading digital health solutions that are science-based, evidence-led, and human experience-driven. Thoughtful risks and quick decisions come together to accelerate innovation across the life sciences sector. Be part of a diverse team that pushes the boundaries of science by digitally empowering a deeper understanding of the patients we’re helping. Launch pioneering digital solutions that improve the patients’ experience and deliver better health outcomes. Together, we have the opportunity to combine deep scientific expertise with digital and artificial intelligence to serve the wider healthcare community and create new standards across the sector. 

Introduction to Role:

As the Software Quality Senior Analyst, you will support the development and execution of the Internal Audit Program and Client Audit Process for the Evinova Business within AstraZeneca.  You will ensure organizational readiness for each audit and be a trusted team member involved in the conduct and completion of all actions resulting from the audit itself, you will also be charged with tracking and trending of audit-related findings to be reported as part of the Quality Management Review and help support the Nonconformance and Supplier Qualification processes.

Accountabilities:

Internal Audit Management

• Support the yearly internal audit program by helping execute the audit plan based on business needs with direction from department leaders
• Conduct audits per plan while also leveraging QA colleagues as required
• Manage audit findings and corrective actions from audit closeout to follow-up to closure

Client Audit Management

• Partner as a key lead for the audit process from intake to closure, including:
  • Managing audit calendar and requests intake
  • Manage the audit preparation and readiness process
  • Be an audit host and help facilitate the audit
  • Manage audit findings and corrective actions from audit closeout to follow-up to closure
  • Partnering with the Learning and Development team ensure all internal resources are trained on how to conduct themselves during an audit
     

Supplier Qualification Management

• Assist in the assessment of suppliers based on risk as required by the business

Tracking and Trending of Audit Issues & Audit Finding Resolution

• Ensure all audit observations and findings are worked thru to closure based on committed timelines per audit
• Track and trend all audit issues to be included in as part of the Quarterly Quality Management Review

Nonconformance Processes

• Working under the direction of QA Leadership help lead root cause investigation and process improvement activities resulting from audit activities and/ or reported issues with our products and services
• Facilitate Corrective and Preventative Action process as required

Essential Skills/Experience:

• Bachelor’s degree in a relevant field (Information Systems, etc.) or equivilent working experience
• 5+ years of experience in a Quality Assurance related role, preferably within a SaaS software or life sciences environment.
• Excellent communication skills with the ability to engage and inspire diverse audiences.
• Knowledge of clinical trial processes and life sciences industry (pharmaceutical, biotech, medical device companies, CROs, and academic/public health