Job Title: Software Quality Document Manager - 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.

Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Introduction to Role:

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.

As the Quality Document Manager, you will own the Quality Management System (QMS), Master Control, from the perspective of document control, maintenance, review and approval and continual buildout of key process areas and templates. You will ensure completeness of our QMS for accuracy and detail for all key process areas across the business and be charged with ensuring timely upkeep, periodic reviews and assignments of training, as well as educating and working with teams on the use of the application and future enhancements as required. Further you will partner with others to facilitate investigation of issues and supplier management documentation within the application. You will also be charged with reporting gaps and issues with the QMS and leading the sharing of documentation requests for clients during audits or needed otherwise.

Accountabilities:

Essential Skills/Experience:

Bachelor's degree in a relevant field (Information Systems, etc.)
Experience in the Life Science industry requiring controlled processes in place that are routinely reviewed and updated
Excellent communication skills with the ability to engage and inspire diverse audiences.
Detail-oriented with strong analytical and troubleshooting skills.

Desirable Skills/Experience:

Knowledge of QMS platforms such as Master Control and Veeva
Previous audit experience in life sciences.

So, what's next?

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.

Total Rewards:

The annual base pay for this position ranges from $118,641.60 to $177,962.40. 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.

#LI-Hybrid

Date Posted

25-Nov-2024

Closing Date

08-Dec-2024Our 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.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.