Assoc Director, Business Strategy and Operations

At Gilead Sciences Canada Inc. we take pride in being recognized as one of Greater Torontos Top Employer 2024. Click here to find out why Gilead Sciences Canada is a top employer!

Chez Gilead Sciences Canada Inc. nous sommes fiers dêtre reconnus comme lun des meilleurs employeurs du Grand Toronto pour 2024. Cliquez ici pour en savoir plus sur les raisons de notre succès.

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

Key Responsibilities

Regulatory Operations & Process Improvement

• Lead business process mapping analysis design and optimization initiatives across CMC Regulatory Affairs including development registration post-approval and lifecycle management activities.

• Identify operational pain points process gaps inefficiencies and opportunities for simplification or digital enablement in partnership with process owners and subject matter experts.

• Apply structured problem-solving and data-driven approaches to evaluate root causes assess options and develop practical and sustainable solutions.

• Facilitate cross-functional workshops and working sessions to define current and future-state processes clarify roles and decision points and establish implementation plans.

• Support the development and maintenance of process standards procedures governance mechanisms and operational controls that enable consistent execution across CMC Regulatory Affairs.

• Develop and monitor operational measures and KPIs to evaluate process performance adoption and opportunities for continued improvement

• Support portfolio resource and operational planning activities as needed including use of enterprise planning and resource forecasting tools.

Digital Enablement Data & Systems

• Partner with the CMC Digital Enablement Head business process owners IT and other stakeholders to identify and advance digital opportunities that address meaningful regulatory business needs.

• Translate regulatory operational needs and process requirements into clear business requirements and use cases for digital automation data and technology solutions.

• Lead or support the implementation of digital solutions from business problem definition and requirements development through testing deployment adoption and continuous improvement.

• Establish and monitor success metrics for digital and AI-enabled capabilities including adoption operational efficiency quality user experience and business value realization.

• Evaluate opportunities to apply workflow automation analytics artificial intelligence and emerging technologies to improve regulatory processes and decision-making.

• Support integration of regulatory processes data content and systems to enable more connected and efficient ways of working.

• Partner with data and system owners to improve data quality usability and availability for regulatory operations analytics and decision-making.

• Develop dashboards metrics and operational insights that increase visibility into performance and enable data-driven decisions.

• Support user acceptance testing implementation readiness change management and adoption of new or enhanced digital capabilities.

Cross-Functional Delivery & Change Leadership

• Lead complex cross-functional initiatives involving CMC Regulatory Affairs Regulatory Affairs Technical Development Quality Manufacturing Supply Chain Strategy & Operations IT and other relevant stakeholders.

• Establish clear project objectives scope deliverables roles dependencies and implementation plans for assigned initiatives.

• Build alignment among stakeholders with differing priorities and translate complex operational or technical topics into clear business decisions and actions.

• Develop recommendations and decision materials for CMC Regulatory Affairs leadership based on analysis of operational challenges opportunities risks and potential solutions.

• Partner with Regulatory Policy Intelligence and Health Authority Strategy colleagues to ensure processes and solutions remain aligned with evolving global regulatory requirements and expectations.

• Drive organizational change initiatives to successfully implement new processes digital tools and AI-enabled ways of working including stakeholder engagement communications training adoption strategies and measurement of expected outcomes.

• Promote effective process management and digital ways of working across CMC Regulatory Affairs by sharing tools methodologies lessons learned and scalable approaches.

Qualifications

• BA/BS in Life Sciences Engineering or related field preferred with relevant industry experience 10 years with BS/BA; 8 years with MS/MA/MBA

• Experience in regulatory operations CMC Regulatory Affairs pharmaceutical development or a related regulated environment.

• Demonstrated experience leading business process design mapping optimization or operational improvement initiatives.

• Experience translating business needs into requirements and partnering with technology teams to implement digital or system-enabled solutions.

• Experience leading complex cross-functional initiatives in a global and highly matrixed organization.

• Strong understanding of pharmaceutical regulatory processes and the regulatory lifecycle; experience with CMC regulatory processes strongly preferred.

• Familiarity with regulatory information management document/content management workflow data analytics automation or AI-enabled solutions.

• Experience with relevant enterprise platforms and tools such as Veeva Vault Planisware Signavio Visio Power BI or similar technologies is desirable.

• Demonstrated ability to analyze complex problems structure ambiguous issues develop recommendations and drive work through implementation.

• Strong facilitation skills with demonstrated ability to gather subject matter expert input and translate it into clear practical end-to-end processes and requirements.

• Strong communication and influencing skills with the ability to work effectively across functions and organizational levels.

• Lean Lean Six Sigma or other process improvement training or certification is desirable; demonstrated practical application of process improvement methodologies is more important than certification alone.

Please apply via the Internal Career Opportunities portal in Workday.

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