Digital Therapeutics Platform Quality Lead - (OFR0251)
Platform Quality Lead - Digital Therapeutics
Job Description / Capsule
At AstraZeneca, we lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do groundbreaking, outstanding work that has big impact on science and medicine. We explore innovations and confront challenges that others won't, in order to have a greater impact on patients' lives.
AstraZeneca’s Digital Health R&D and IT functions partner closely with a common goal of dramatically improving patient experience and outcomes. We are contributing to the transformation of healthcare, re-setting expectations on how to augment patient outcomes by using digital health solutions in combination with life-changing treatments. This is a strategic priority that we are scaling rapidly from a significant number of pilots in the last 5 years. AstraZeneca would like to leap frog in this area and has prioritized digital in R&D as a critical strategic area of focus by 2025, as part of the overall company strategy. We seek strong talent to join our teams in delivering on this ambition!
The Digital Health R&D journey incorporates 3 key stages:
- Stage 1 – foundational, reimagining how we work, by improving the use of digital, data and analytics to transform processes within R&D – delivering significant benefits on speed of portfolio delivery (goal of 9 months acceleration) efficiency (goal of 20% reduction in cost per patient per year), quality at source, patient experience and probability of success.
- Stage 2 – sophisticated, redefining clinical trials and digital health to improve overall patient experiences and outcomes, such as redefining patient populations, conducting remote clinical trials, developing patient apps to reduce/lead adverse events and improve patient outcomes (Overall Survival), using data from EMR/EHR and RWD instead of control arms, conduct continuous patient monitoring through PROs, and creating new end points enabling studies in earlier stages of disease (ctDNA changes).
- Stage 3 – future-readiness, reimagining healthcare, such as AZ as a healthcare provider beyond medicines for certain indications (example: Breast Cancer, providing monitoring, predictive analytics and therapies for improved outcomes), full integration of Multiomics (imaging, genomics, proteomics …) to better predict and significantly improve patients’ health
We are making significant investments in our Digital Therapeutics delivery capability. As part of this investment, we are creating a team focused on delivering Digital Clinical Trial Support, Digital Therapeutics, and Digital Patient Support capabilities. As we look to strengthen our delivery capability, we are creating a new team specifically for this journey. The Digital Therapeutics Platform Quality Manager is a key part of the foundations of our new team.
In this role you will own our team’s quality pertaining to GxP, Software as a Medical Device (SaMD) and software testing practices. We would like to create an end to end delivery team like we have never before. Therefore we will be bending and blurring the accountabilities of traditional IT roles. Everyone will need to be comfortable with this and thrive on this opportunity to be different. We are looking for a unique leader in this space as you will be expected to lead through influence and guidance rather than direct line management due to our distributed teams. Our expectation is to create a team that is greater than the sum of its parts. This means that titles are left at the door as we all drive towards the same goal. Our portfolio will be a mixture of 3rd party partnerships, SaaS implementations, custom software engineering product delivery, or any combination of these examples. All our initiatives will be healthcare focused and will be heavily supervised. Software will play an instrumental role in the capabilities we deliver, and we seek someone who not only has experience in software delivery, but also has an in-depth understanding of how to deliver software in a product methodology and has an appreciation for the software engineering process.
We thrive on exploration of ideas, leadership and having teammates who are highly collaborative through the good times and bad. Put simply, this means having humility, fueling inspiration, inspiring others through exciting times, taking accountability for your work and the team, feeling the need to continually raise the expectations of yourself and others, and lastly being a true problem solver.
As our Platform Quality Manager you will be accountable for the quality and testing processes our internal teams will follow. It is important that you understand the impact of our solutions and the quality of our solutions, bring that knowledge back into our delivery teams. To be successful in this role you will need to enable the team, not slow the team down while making quality, testing, GxP, Data Privacy, and Software as a Medical Device part of our culture.
You will need to demonstrate compliance subject matter expertise aligned with agile delivery practices, product management, product design, and engineering to enable our teams to accelerate delivery of business capabilities, reduce time to value. As a leader, you will need to implement compliance innovations to build quality compliance into delivery processes in partnership with AZ quality management. Act as a partner with AZ quality and compliance teams. Improve our internal processes.
- Build a testing and quality management strategy for the team.
- Design and implement a plan for internal and external audit compliance automation.
- Establish, supervise, and report on metrics that not only measure our adherence to the quality processes but also positively influence team behaviors.
- Lead a R&D Digital Health quality counsel focused on enabling and accelerating the delivery of GxP and Software as a Medical Device solutions.
- Lead the testing and quality standards of the team.
- Lead the documentation of the teams testing and quality standards.
- Establish and lead a continuous improvement program that that embeds quality, GxP, Software as a Medical Device practices into our engineering patterns.
- Provide mentorship to Quality Managers and other team members on quality practices.
- Partner with AstraZeneca quality management teams.
- Lead the quality and compliance validation of 3rd party vendors and products.
- Influence AstraZeneca’s internal quality and compliance practices.
- Represent the team in both internal and external audits.
- Conduct mock audits to assess audit readiness of both the team and our documentation.
- Own risks, exceptions, and partner concerns related to quality management and testing.
Education, Qualifications and Experience
- Bachelor’s degree in an appropriate field is preferred but not required. We will hire self-taught team members and leaders without a formal education given you have evidence of rich history product delivery.
- High ethical standards with an understanding of ethical decision making.
- Preferred experience with prior medical solutions delivery with GxP requirements, oncology related solutions delivery, or equivalent.
- Extensive knowledge related to cloud computing, regulatory, security, privacy, software engineering, and ethical use of patient information.
- Ability to discuss ethical and regulatory issues with credibility.
- Rich experience in bio-pharma industry, specifically in Oncology clinical development and commercial launch
- Deep knowledge and understanding of the Clinical Development domain.
- Extensive knowledge of scientific and clinical pharmaceutical processes.
- Confirmed ability to interpret and communicate technical and scientific information.
- A consistent track record of delivering results.
- Ability to travel both domestically and internationally.
- Experience working across diverse, global teams
Skills and Capabilities
- Excellent verbal and written communication skills including presenting
- Program management leadership with experience of cross geography, high value implementations
- Excellent influencing, networking and team working skills
- High level awareness of developments in the Information Technology marketplace
- Able to run and lead negotiations, expectations and solutions across sophisticated partner groups
- Experienced relationship building skills with the ability to influence others to achieve objectives
- Expertise in planning, change management and problem solving and able to resolve issues of a highly complex and strategic nature
- Confirmed ability to relate and respond to business needs in an IT environment
- Ability to work well in and across diverse global teams
- Ability to partner and work in a matrix organisation
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.