Director, IT - ERP, CMC & Corporate Job at Kiniksa Pharmaceuticals
Reporting to the Vice President of IT and serving as a member of the IT Leadership team, the Director of IT for ERP, CMC and Corporate Systems will be responsible for setting the direction, executing projects and delivering support for IT applications, including those in the following areas:
- Corporate Systems (Human Resources, Compliance, Legal, & Finance)
- Enterprise Resource Planning (ERP/SAP)
- Chemistry & Manufacturing Controls (CMC - Supply Chain, Quality Assurance, Quality Control, Internal and External Manufacturing)
This role must be based in one of our office locations in Lexington, MA, San Diego, CA or London, UK. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
- Relationship management for each of the business partners leading the listed business functions. This includes serving as the IT point of contact to these business functions, anticipating their future technology needs, and maintaining the short and long-range planning for supporting their business application needs
- Collaborate with assigned business partners in the listed business functions on projects, daily operations, and issue resolution. Participate in business partner key planning sessions, regular operational meetings, and staff meetings as appropriate
- Serve as the Executor for the ERP & Corporate Systems Steering Committee, the governance group in place for the suite of systems and services
- Provide Program and Project Management for key projects and initiatives. Oversee direct reports, providing Project Management for their projects and ensuring the delivery of high-quality solutions that meet business needs
- Provide oversight and expertise for troubleshooting production issues, providing resolutions and conducting root cause analysis
- Directly manage, provide oversight to, and ensure high quality and service standards are achieved with Managed Service Providers and Software as a Service providers
- Working with the VP of IT and others on the IT Leadership team, author and update annually the long-range IT strategy and solutions portfolio, associated roadmaps and financial forecasts. Manage the budget for your assigned area
- Coach, develop and manage a team, defining organizational and individual goals and facilitating individual development plans
- Develop policies, SOP’s and work instructions as needed to ensure efficient and compliant operations of supported systems, including supporting GxP and SoX compliance. Support Finance and Compliance teams with company compliance reporting initiatives. Lead and manage annual IT SoX testing and provide support to internal and external auditors
- Participate in regulatory inspections (SEC, FDA, EMA, MHRA, etc.) as needed to provide Subject Matter Expertise
- Demonstrate Kiniksa’s cultural values of integrity, transparency and humility while embracing “every second counts” mindset
- Other project and initiatives as assigned
Qualifications:
- Requires a Bachelor’s degree in Computer Science or related field (MBA a plus) with 15+ years as an information technology leader with 10+ years in a techno functional SAP ERP solution design, build and delivery with hands on experience with SAP S4/HANA
- Broad understanding of the business processes supported, and an understanding of GxP compliance in a biotech or pharmaceutical environment is highly desired
- Demonstrated success delivering ERP solutions including analyzing current processes, identifying requirements and opportunities to enhance current business processes, and executing both large and small projects
- Acts as a thought leader or subject matter expert, as needed, to collaborate with cross functional business groups and drive discussions to decisions in a timely manner
- Success leading technical development efforts and designing and managing a scalable, cost-effective onsite/off-shore development and support model with third parties.
- Strong working knowledge of SoX IT controls, compliance reporting, and applicable US and European data privacy laws
- Demonstrated, hands-on experience as a project manager with strong planning skills, the ability to set and manage expectations and deliver on projects within the committed timeframe and budget
- Demonstrated ability to analyze problems and resolve conflicts. Results oriented and the ability work independently and meet deadlines
- Ability to work in a fast-paced environment and meet tight periodic reporting deadlines
- Ability to work in a small company environment and contribute to different functions
- International experience is highly desired
- Excellent communicator, both written and oral, to act as a cross-functional business partner
- Detail oriented, with an analytical approach to supporting the strategic decision-making process.
- Highest ethical standards
- Strong interpersonal skills and the ability to develop and maintain effective relationships in a diverse organization
All Kiniksa new hires whose roles require them to enter Kiniksa’s physical offices will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief. Requests for accommodation will be considered on a case-by-case basis, and Kiniksa will consider, among other things whether a proposed accommodation would create an undue hardship.
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