Associate Director/director, Quality, Regulatory

2 weeks ago

Boston, United States Xenon Pharmaceuticals Inc. Full time

**Who We Are**:
**Xenon Pharmaceuticals (NASDAQ**: XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders. We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.

**What We Do**:
**About the Role**:
This Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) System role is a hands-on position with the expectation that their team will expand over time as new systems are implemented and as the IT operating model evolves. During this period of rapid growth and evolution, the Associate Director/Director, Quality, Regulatory & Supply Chain (QR&SC) System will be assigned additional responsibilities (beyond the core responsibilities described) based on company needs, the individual’s experience and expertise, and the availability of resources within IT.

**RESPONSIBILITIES**:

- Act as the IT owner for all QR&SC systems and collaborate with functional system owners and colleagues in IT to evolve the support model based on the needs of the users and the overall IT strategy.
- Partner with key stakeholders in the QR&SC functions to develop and execute against a functional technology roadmap encompassing current and future systems to address existing pain points, maximize the usage and value of existing systems, and develop new capabilities as needed.
- Serve as the primary point of contact between the QR&SC functions and IT to resolve issues, align on processes and standards, and ensure awareness and alignment on key initiatives (function
- or IT-sponsored). Ensure that IT standards and processes are tailored to meet the unique needs and capabilities of the QR&SC functions.
- Facilitate effective IT planning, governance, and project delivery as these processes evolve.
- Actively collaborate with other IT business partners to manage common or cross-functional requirements and project dependencies, and to ensure an effective enterprise approach to system planning and design.
- Collaborate with the Associate Director/Director, Data Architecture & Engineering to ensure effective and secure data exchange with external vendors and service providers, and to facilitate the design and adoption of effective data governance and lifecycle management processes and tools to control data lineage.
- Design, develop, and document effective data flows and integrations among systems to enable efficient processes and workflows (including automation) and effective reporting and analytics.
- Collaborate with functional stakeholders and with the Quality department to ensure relevant systems are built and maintained in compliance with regulatory requirements and internal policies and procedures.
- Manage vendor relationships (e.g. software and service providers) in the context of both project delivery and ongoing operations to maximize value to Xenon.

As a member of the IT Leadership Team, contribute to the development and execution of the strategy to evolve the overall IT operating model, including new structure, processes, and ways of working.
- Develop and propose short
- and long-term objectives for the function in accordance with overall Company strategies and plans.
- Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
- Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
- Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
- Other duties as assigned.

**QUALIFICATIONS**:

- Minimum undergraduate degree in Computer Science, Informatics, or related discipline.
- At least 8 years of progressive information technology experience in a similar role, with at least 3 years in a leadership/management role.
- Demonstrated ability to set direction and lead while simultaneously performing hands-on work.
- Experience working in a regulated environment including extensive knowledge of system validation requirements and frameworks.
- Domain knowledge of the work performed with the Quality, Regulatory & Supply Chain functions, including the ability to effectively collaborate with functional stakeholders.
- Proven ability to diagnose and solve problems, and to identify opportunities to more effectively leverage technology and data to drive agility, efficiency, insights, and compliance.
- Broad knowledge base of cloud technology offerings as they relate to life sciences.
- Excellent written and verbal communication skills with the ability to explain highly technical information in a concise and effective manner to an audience of varying technical aptitude.
- Strong interpersonal s

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