IT Quality & Compliance Director at AstraZeneca in Boston, Massachusetts

Job Description:

AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your ambitious spirit. There's no better place to make a difference to patients, society and the planet.


As the Director of IT Quality & Compliance, you'll work in the IT Quality & Compliance function of the Strategy, Performance & Quality Function in Global IT. This role is crucial to accelerating our compliance efforts as we integrate new technologies, like AI, that require a fundamental rethinking of compliance capabilities, frameworks, and delivery mechanisms to ensure all IT projects and services achieve compliance.



Accountabilities:



As the IT Quality Management Director, you will lead a team of experts who ensure that our IT systems and services are compliant, reliable, and ready for any inspection. You will work across projects and services at a global scale, supported by a regional structure. You will be responsible for defining and completing the IT Quality strategy, leading all aspects of the direction, performance, and delivery of IT Quality services. You will also set and interpret the highest standards of IT and related compliance policies for both GxP and SOx.



Essential Skills/Experience:

• Bachelor's Degree


• Minimum 7+ years of experience


• Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP, GxP, ITIL, S404 Sarbanes Oxley


• Extensive experience in multiple areas of quality and compliance within a Pharmaceutical/Biotech environment


• Developing quality, compliance and risk strategies and articulating the strategic direction for regulated organisations


• Design and implementation of Quality Systems as integral to an overall Business System


• Leading diverse groups of senior quality, compliance and business collaborators with varied and often conflicting priorities


• Establishing and running Quality and Compliance organisations


• Continuous improvement/Compliance Improvement


• External Advocacy representing global organisations and collaborating with quality/compliance/risk related external industry forums/trade associations


• Setting Standards by translating regulatory requirements and expectations into 'fit for purpose' internal policies and standards for effective business controls


• Driving risk, quality and compliance assurance across multiple aspects of global operation


• Internal auditing and external regulatory inspection management


• Proven challenge, negotiation & influencing capabilities


• Strong Change Management Leadership


• Strong collaboration and relationship building skill with both internal and external collaborators, enabling effective enterprise collaboration


• Strong people development skills, attracting talent and investing in long-term development of others


• Highly constructive and enabling mentor


• Presentation, Communication & Facilitation skills


• Strong leader, drives accountability and encourages the organization to do the right thing


• Pragmatic decision making - analyses highly complex situations, assessing risks and balancing strategic and tactical compliance/quality requirements


• Tenacity - challenges the status quo by surfacing challenging and complex issues to get simple and desirable outcomes


• Ability to stay calm under pressure


• Actively identifies untapped opportunities and drives benefit realisation

Desirable Skills/Experience:

• Broad IT management experience including project or service management


• Familiarity with technical concepts in infrastructure or applications


• External qualifications such as ISPE PCC CPIP and ISACA CISM


• Ability to drive innovation in a Compliance and Quality environment

In-Office Expectation:



When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and daring world.



Why AstraZeneca?



Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Make the impossible possible by building partnerships and ecosystems, creating new ways of working and driving scale and speed to deliver exponential growth. Focused and committed, and backed with the investment to succeed, we're driving cross-company change to reinvent the entire industry. Be part of a team that has the backing to innovate, redefine an industry and change lives. We're a network of entrepreneurial self-starters who contribute to something far bigger.


Ready to make your mark? Apply now!


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 authorization and employment eligibility verification requirements. Apply Now