Software Quality Audit Director

Job Title: Software Quality Audit Director
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 Audit Manager, you will lead the development and execution of the Internal Audit Program and Manage the Client Audit Process from start to finish.  You will ensure organizational readiness for each audit and be the primary person responsible for 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 process.

Accountabilities:

Client Audit Management

• Lead and own the client audit process from intake to closure, including:
  • Managing audit calendar and requests intake
  • Manage the audit preparation and readiness process
  • Be the primary audit host and facilitate the audit
  • Manage audit findings and corrective actions from audit closeout to follow-up to closure

Internal Audit Management

• Build and maintain the yearly internal audit program and schedule
• Conduct audits per plan while also leveraging QA colleagues and external resources as required
• Manage audit findings and corrective actions from audit closeout to follow-up to closure

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

Audit Readiness and Training

• Partnering with the Learning and Development team ensure all internal resources are trained on how to conduct themselves during an audit

Essential Skills/Experience:

• Bachelor’s degree in a relevant field (Information Systems, etc.); a Master’s degree is preferred.
• 10+ years of experience in an Audit Manager related role, preferably within a SaaS software or life sciences environment.
• Strong leadership and team management skills, with prior experience in people management.
• 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).
• Detail-oriented with strong analytical and troubleshooting skills.