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 leadersConduct audits per plan while also leveraging QA colleagues as requiredManage 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 intakeManage the audit preparation and readiness processBe an audit host and help facilitate the auditManage audit findings and corrective actions from audit closeout to follow-up to closurePartnering 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 auditTrack 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 servicesFacilitate Corrective and Preventative Action process as required

Essential Skills/Experience:

Bachelor’s degree in a relevant field (Information Systems, etc.) or equivilent working experience5+ 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 organizations).Diligent with strong analytical and troubleshooting skills.Thrive in collaborative environments, working with peers to overcome challenges and improve processes.Adaptable and able to adjust strategies in response to changing business needs.Proactively identify and communicate potential compliance risks to cross-functional teams, ensuring early mitigation.

Desirable Skills/Experience:

Experience working in a fast paced, global, and highly technical environmentPrevious Quality experience in life sciences.

Where can I find out more?

Learn more about Evinova www.evinova.comOur Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

Why Evinova?

Evinova is a global health tech business, separate company part of the AstraZeneca group. Together, we can accelerate the delivery of life-changing medicines, improve the design and delivery of clinical trials for better patient experiences and outcomes, and think more holistically about patient care before, during, and after treatment.  We know that regulators, healthcare professionals, and care teams at clinical trial sites do not want a fragmented approach. They do not want a future where every pharmaceutical company provides its own, different digital solutions. They want solutions that work across the sector, simplify their workload, and benefit patients broadly. By bringing our solutions to the wider life sciences community, we can help build more unified approaches to how we all develop and deploy digital technologies, better serving our teams, physicians, and ultimately patients.  Evinova represents a unique opportunity to deliver meaningful outcomes with digital and AI to serve the wider healthcare community and create new standards for the sector.  Join us on our journey of building a new kind of health tech business to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting-edge methods, and bringing unexpected teams together. Interested? Come and join our journey.

Total Rewards:

The annual base pay for this position ranges from $99,744.80 to $149,617.20. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

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Date Posted

07-Feb-2025

Closing Date

20-Feb-2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.