At Gilead Sciences Canada Inc. we take pride in being recognized as one of Greater Toronto’s Top Employer 2024. Click here to find out why Gilead Sciences Canada is a top employer!
Chez Gilead Sciences Canada Inc., nous sommes fiers d’être reconnus comme l’un des meilleurs employeurs du Grand Toronto pour 2024. Cliquez ici pour en savoir plus sur les raisons de notre succès.
At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s 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 we’re 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.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
The salary range for this position is CAD $158,355 - $204,930 annually. In addition, this role is eligible for a discretionary target annual bonus. Gilead determines base compensation by considering factors such as experience, qualifications, and geographic location. As a result, actual compensation may vary.AI Clause
We use AI-enabled tools to support our recruitment process. All hiring decisions are made by our recruitment team.
Skills Required
- BA or BS in Life Sciences, Engineering, or a related field with 10+ years of relevant industry experience
- MS, MA, or MBA with 8+ years of relevant industry experience
- Experience in regulatory operations, CMC Regulatory Affairs, pharmaceutical development, or a related regulated environment
- 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, highly matrixed organization
- Strong understanding of pharmaceutical regulatory processes and the regulatory lifecycle
- Experience with CMC regulatory processes
- Familiarity with regulatory information management, document and content management, workflow, data, analytics, automation, or AI-enabled solutions
- Experience with Veeva Vault, Planisware, Signavio, Visio, Power BI, or similar technologies
- Ability to analyze complex problems, structure ambiguous issues, develop recommendations, and drive implementation
- Strong facilitation skills and ability to translate subject matter expert input into practical processes and requirements
- Strong communication and influencing skills across functions and organizational levels
- Lean, Lean Six Sigma, or other process improvement training or certification
- Practical application of process improvement methodologies
Gilead Sciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Gilead Sciences and has not been reviewed or approved by Gilead Sciences.
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Fair & Transparent Compensation — Pay is considered competitive and fair relative to roles, frequently cited as a standout strength. Feedback suggests compensation compares well within biotech and is a notable reason employees feel valued.
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Equity Value & Accessibility — Stock awards and an employee stock purchase program are consistently described as meaningful parts of total compensation. Equity components are seen as accessible and enhance long‑term wealth building.
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Retirement Support — A strong company 401(k) match with immediate vesting is often singled out as a differentiator. This support is perceived to significantly boost long‑term financial security.
Gilead Sciences Insights
What We Do
The way we see it, the impossible is not impossible. It’s simply what hasn’t been achieved yet. For more than 30 years, we’ve pursued it, chased it down, tackled it for answers and surrounded it for a way in. We have worked tirelessly to bring forward medicines for life-threatening diseases. Creating Possible drives everything we do. It’s evident in our mission and core values. This is how we built a culture of excellence that is fueled by a passion for improving lives of people around the world. For us, nothing is impossible – because of the people we work with, the communities we stand with and the partners we push forward with. Our ~12,000 employees band together through science, grit, compassion and courage to prove the impossible wrong. At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?” Social Media Guidelines: https://gilead.inc/3t1m7d5
