Associate Director, R&D & Operations GxP Systems

This is what you will do:

We are seeking an experienced IT professional with 7-10 years of biopharmaceutical experience and a focus on quality and regulatory inspections to join our team as Associate Director, R&D & Operations GxP Systems on the RDU R&D IT team. In this role, you will be responsible for oversight of Compliance & IT Quality processes and services that assure that IT projects, systems, products and services effectively apply relevant Policies, Standards and processes, and lead Health Authority inspections preparation and execution. You will also be the primary contact for merger and acquisition activities that impact the RDU R&D IT organization.

You will be responsible for:

Key Areas of Responsibility will include:

• Lead GxP activities, including oversight of training commitments, procedural controls, changes, deviations, corrective actions, and inputs into emerging policies for efficient compliance to regulations.

• Develop, communicate and collaborate on the continuous improvement of Compliance & IT Quality policies standards and procedures.

• Using a risk-based approach, drive the identification and implementation of innovative Compliance and IT Quality solutions to address business needs, identifying opportunities for and driving cross functional working to drive improvement and achieve efficiencies

• Identify, manage and resolve IT quality, compliance risks and issues and oversee resolution and reporting.

• Ensure Compliance & IT Quality requirements are embedded throughout project and service lifecycle activities.

• Monitor Compliance & IT Quality requirements that IT products and services must effectively comply with.

• Manage vendor partnerships and engagement to ensure operational support for key internally managed computer systems for the Rare Disease Unit R&D departments.

• Prepare and execute RDU R&D IT responsibilities for Health Authority inspections, including identification and reporting of applicable computer systems and adherence to processes.

• Serve as the primary team contact on mergers & acquisitions (M&A) activities to provide due diligence, transition planning, and execution.

• Communicate operational and project status regularly to senior leadership.

• Drive the execution of IT projects in collaboration with suppliers, business partners, team, and management.

You will need to have:

• Strong IT background with experience in R&D engagement, vendor oversight, GxP compliance, partnering with senior management.

• Proven track record of innovation utilizing, technology, partners and teams tied to business outcomes.

• Detail-oriented, self-starter and able to work both independently and in a team environment.

• Experience managing technical resources and project teams.

• Strong analytical and critical thinking skills.

• Ability to manage multiple priorities under tight timelines.

• Understanding of PMI methodologies and project management experience.

• Proven track-record of delivering IT projects utilizing waterfal metholodies and/or agile SDLC.

• Excellent verbal communication skills.

• Experience with formalized change management processes.

• Technical and procedural documentation proficiency

• Expertise in regulatory (GxP) and corporate compliance domains.

• Ability to act decisively when empowered.

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• The ideal candidate for this role has a minimum of 7 years working in the biopharmaceutical industry with exeprience in R&D IT and vendor oversight activities.

• Undergraduate degree in computer science, information technology, business, or related field.

• Desired: Advanced degree in computer science, information technology, business, or related field

• Prior experience integrating systems from acquisitions.

• Mastery of both regulatory (GxP) and corporate compliance domains

Since beginning our operations in Canada in 2009, Alexion has been working tirelessly to bring innovative medicines to the millions of Canadians living with rare diseases. Our pioneering 30-year legacy, our scientific expertise and our commitment to patient-centric decision-making are the foundations of what we are today – a company with a mission to transform lives.

Our Canadian team

We know that people living with a rare disease and their families deserve our unwavering commitment and investment into finding and accessing therapies that help them live longer, fuller lives. Our presence in Canada has grown to over 200 employees and includes a global research and development hub, made up of highly skilled professionals responsible for conducting our clinical trials in Canada and around the world, as well as our dedicated and passionate local teams that ensures our treatments reach those who need them. Together, we are driving patient impact locally and globally.

How we work
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 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 ambitious world.

Alexion 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. Alexion 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.

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.