Director, Project Management (Future of Work Program), Ontario

Kyowa Kirin

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, ERP Functional & Solution Architect, ICT role will be responsible for overseeing MS D365 Enterprise Resource Planning (ERP) within the organization. Crucial role in implementing ERP specific business process improvements and enhancements within the organization and ensuring the system's optimal performance and functionality. Perform the planning, design, configuration, customization, and implementation of MS D365/ERP modules and functionalities, ensuring seamless integration with existing systems, ensuring compliance with industry standards, security protocols, and regulatory requirements. The ERP Functional Architect, Associate Director, ICT role will also serve as a business process analyst aligned with enterprise (i.e., SCM, MFG, Quality) and Corporate Functions (i.e., Finance, HR, Legal, Compliance, Procurement) ensuring successful technical solution development and delivery. Essential Functions: The D365 ERP F&O Functional Architect is responsible for the end-to-end functional design, configuration, and optimization of Microsoft Dynamics 365 Finance & Operations to support business operations across Finance, Procurement, Supply Chain, Manufacturing, Quality, and related business functions. The architect will partner with business stakeholders, technical teams, and implementation partners to ensure that the solution is aligned with corporate strategy, compliant with GxP/GAMP 5 standards (where applicable), and scalable for future business growth. 1. Solution Architecture & Design •    Lead the functional design and architecture of the D365 F&O solution across key modules (Finance, Supply Chain, Manufacturing, Procurement, Inventory, Quality, etc.). •    Translate complex business requirements into clear, scalable, and compliant functional solutions. •    Emphasizes proactive, holistic leadership in solution architecture. •    Focuses on aligning solutions with business goals, value streams, and enterprise architecture governance. •    Define data flows, integrations, and system interactions between D365 and other enterprise systems & interfaces (e.g., LIMS, MES, 3PL Partners, External Finance Systems, and Cloud systems). •    Ensure alignment with Microsoft’s Dynamics 365 roadmap and best practices. 2. Implementation & Configuration •    Perform and lead the setup, configuration, and deployment of D365 F&O modules.  •    End to end management of project/solution management by using tools like Azure Boards for planning and tracking work, Azure Repos for code versioning, and Azure Pipelines for automating build and deployment. Perform all activities from initial user stories and tasks to code, testing, and deployment through integrations with tools like Lifecycle Services (LCS).  •    Drive fit-gap analysis and functional documentation. Develop User/Functional Requirements, Functional/Technical Design, System/Business process architecture diagrams. •    Collaborate with development/vendor/managed service teams to define functional specifications for enhancements, bug/fix, customizations, reports, and interfaces. Co-develop or individually develop code/configurations required and coordinate internal development and user acceptance testing of the solution. •    Participate in system validation activities, including IQ/OQ/PQ documentation for regulated environments. 3. Governance & Compliance •    Ensure the ERP system design complies with GAMP 5, SOX, and GxP regulatory requirements. •    Develop and maintain master data governance, change management, and configuration control processes. •    Support audits and inspections through proper documentation and traceability. •    Develop current and future state roadmaps and architecture. •    Assess and align system release plan with Microsoft Dynamics 365 roadmap 4. Stakeholder Collaboration •    Partner with business process owners to define best practices, continuous improvement opportunities, and confirm desired solution to fix the support/bug-fix items raised. Support communities of practice and collaborative development methodology. •    Work independently to perform required fix within the D365 framework. Test and confirm the developed fix with business process owners.  •    Work closely with IT, OT, and cloud teams to ensure integrated digital architecture. •    Provide subject matter expertise and training for internal business process owners and super users. 5. Project & Vendor Management •    Support ERP implementation and upgrade projects through all phases — initiation, design, testing, go-live, and hypercare. •    Manage and coordinate external implementation partners and vendors. •    Define KPIs and monitor system performance, adoption, and ROI. Requirements: Education  Bachelor’s degree or equivalent experience in computer science, information systems, engineering, supply chain, or related fields required. Microsoft D365 F&O Certification preferred. Experience •    8+ years of experience implementing or supporting Microsoft Dynamics AX / D365 F&O. •    Proven expertise across multiple functional domains (Finance, Manufacturing, Supply Chain, Procurement). •    Experience designing integrations between ERP and external systems (LIMS, MES, Payment interface with Bank, External Finance Systems, etc.). •    Strong understanding of ERP data models, workflows, and reporting. •    Strong understanding of functional and solution architecture of, and experience performing code and configuration updates within the following Dynamics 365 modules: o    Finance: General ledger, Cash and bank management, Accounts payable, Accounts receivable. Budgeting, Fixed assets, Cost accounting, PR/PO process, Vendor Management, Cost Accounting and Management  o    SCM: Inventory management, Master planning, Procurement and sourcing, Product information management, Production control, Warehouse management, Cost accounting, Cost management, Asset management, including scheduled maintenance and repair tasks  Technical Skills •    Proficient in MS Office Suite. Experience with technology delivery applications across solutions such as (ERP, Manufacturing Execution Systems, Finance Systems, Control Tower).  •    Microsoft Certified: Dynamics 365: Finance and Operations Apps Solution Architect Expert certification preferred. •    Experience with emerging technologies (AI/ML, cloud, etc.) as relevant to ERP. Working Conditions: Requires up to 10 % domestic and international travel The anticipated salary for this position will be $165,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

Kyowa Kirin

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials. This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions. The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations. Essential Functions: Risk-Based Quality Management (RBQM) Leadership •    Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance. •    Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors. •    Integrate RBQM principles into study planning, execution, oversight, and close-out activities. •    Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy. Central Risk Identification, Monitoring & Mitigation •    Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks. •    Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials. •    Oversee centralized risk monitoring and trending to enable early detection of critical risks. •    Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons  Learned & Risk Library Management (Core Ownership) •    Establish and maintain a centralized Clinical Risk Library, capturing: o    Known and emerging risks o    Root causes o    Mitigation strategies o    Effectiveness of controls •    Lead lessons learned activities across trials, audits, inspections, and CAPAs. •    Ensure lessons learned are: o    Systematically captured o    Analyzed for trends o    Fed back into RBQM planning, SOPs, training, and future studies •    Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness. Quality Oversight & Regulatory Compliance •    Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs. •    Provide centralized quality oversight across trials, CROs, and vendors. •    Support audit and inspection readiness activities, including: o    Risk-based inspection preparation o    Impact assessments o    CAPA development and effectiveness checks Vendor & CRO Risk Oversight •    Design and implement risk-based oversight strategies for CROs and external vendors. •    Monitor vendor performance using quality metrics and risk indicators. •    Lead or support quality governance discussions with external partners. •    Ensure vendor-related risks are integrated into the central risk library and lessons learned framework. Data-Driven Quality & Continuous Improvement •    Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making. •    Generate enterprise-level risk trend reports and insights for senior leadership. •    Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned. •    Champion a culture of proactive quality and continuous improvement across Clinical Operations. Cross-Functional Collaboration & RBQM Expertise •    Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance. •    Provide RBQM training and coaching to study teams and cross-functional stakeholders. •    Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics. •    Participate as an observing member on assigned study teams to provide real-time quality and risk support. SOP Management & Governance Support •    Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates. •    Support governance activities, senior management reporting, and quality metrics standardization. •    Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support. Requirements: Education •    Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required) •    Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred) Experience •    10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM •    Demonstrated experience leading enterprise or cross-study risk management frameworks •    Strong background in audit/inspection readiness, CAPA management, and vendor oversight •    Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements Technical Skills •    Expertise with RBQM tools, centralized monitoring systems, and risk analytics •    Experience defining and using KRIs, QTLs, and quality metrics •    Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI) •    Exposure to AI or predictive analytics for quality monitoring (preferred) Working Conditions: Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines. The anticipated salary for this position will be $175,000 to $190,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including: * 401K with company match * Annual Bonus Program (Sales Bonus for Sales Jobs) * Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days * Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision) * HSA & FSA Programs * Well-Being and Work/Life Programs * Life & Disability Insurance * Concierge Services * Long Term Incentive Program (subject to job level and performance) * Pet Insurance * Tuition Assistance * Employee Referral Awards The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.  Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. RECRUITMENT & STAFFING AGENCIES Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes. #LI-TT1 #Hybrid #Princeton

DEPT

Please note, this is a talent pool position, not a live role. If you would like to be considered for any future Account Management/Client Services positions at DEPT®, please submit an application and we will be in touch when a suitable opportunity arises. This role is part of our Personalised Content team. We create emotive yet conversion-focused ideas, products and campaigns at scale and speed. Our specialty is hyper-personalised, digital communications that change perceptions, shape new behaviours, and shift market share for our clients including eBay, Walmart, and more! JOB PURPOSE: Here at DEPT®, we are always on the lookout for new talent. Whether you’re looking to kick start your client services career, or are a seasoned Account Manager with mentoring/management experience, we would love to hear from you.   As part of the Client Services team, you will be responsible for building strong relationships with clients while overseeing the delivery of a wide variety of integrated campaigns. You will be required to manage client briefs, plan, assign and review creative as well as manage the overall agency workload in partnership with the rest of the team. You will be working closely with Designers, Copywriters, Developers and other parts of the agency to ensure successful campaign deliveries. KEY RESPONSIBILITIES: * Manage, draft and review client briefs * Ensure client deadlines are met across multiple campaigns and liaising with the Account Director on the teams capacity * Liaise with clients, clarifying questions, managing expectations and proactively communicating status, updates or agency recommendations * Clearly and effectively distill and transfer client feedback to designers, copywriters * Prioritising workloads for the team, and escalating when needed * Maintain a full understanding of the clients’ business, strategies, objectives, brand, audiences, and challenges, advising on the communications solution that best meets their needs, with the objective to becoming a trusted adviser * Build excellent working relationships with key clients – by attending regular meetings, video conference calls, planning sessions, briefing meetings, and participating in evaluation reviews * Ensure success criteria are met and projects are delivered to time and to budget * Work with the team to determine and test creatives across client owned channels WHAT WE ARE LOOKING FOR: * We’re open to the see different levels of experience across different sectors * Agency experience is a plus * Experience delivering a broad range of multi-channel marketing communications including digital and direct, including email and banner experience * Extremely organised, with the ability to manage multiple projects simultaneously * Ability to think strategically * Ability to work within short timeframes and meet deadlines with ease and efficiency, successfully managing schedules and priorities * Highly motivated to learn, grow and improve * Personable, approachable demeanor and motivating team player * Moderate understanding of production and interactive processes * Excellent oral and written communication skills * Ability to manage and develop client and supplier relationships * Basic understanding of financials to effectively manage budgets WE OFFER: * 15 days Paid PTO * 10 Public Holidays + Birthday off * Medical, Dental, and Mental Health Support/Benefits (through Canada Life Insurance) * Learning & growth certifications/certifications * Enhanced Family Leave (after 1 year) * A flexible, hybrid working policy * Buddy Program: You will be paired with a ‘Buddy’ to help you through your first weeks’ at DEPT® * Tons of Office perks in our Toronto office! Enjoy biweekly breakfasts and lunches, tons of free snacks, and of course team events on the regular! * A reputation for doing good. DEPT® has been a Certified B Corp® since 2021 and named ‘Agency of the Year’ at both The Lovies and The Webby Awards. * Awesome clients. Whether big or small, local or global — at DEPT® you’ll get the opportunity to work with clients of all sizes and across all industries. And we celebrate all of our successes together! * The opportunity for possibility. We want to enable you to do what you do best and help you develop your skills further with training, development and certifications. * Global annual DEPT® Cares Month in which employees come together and donate their skills to support local charities.    WHO ARE WE?  We are pioneers at heart. What does that mean? We are always looking forward, thinking of what we can create tomorrow that does not exist today. We were born digital and we are a new model of agency, with a deep skillset in tech and marketing. That’s why we hire curious, self-driven, talented people who never stop innovating.  Our culture is big enough to cope and small enough to care. Meaning, that with people across 30+ countries, we’re big enough to provide you with the best tools, global opportunities, and benefits that help you thrive. While acting small by investing in you, your growth, your team, and giving you the autonomy to solve our clients problems, no matter where you are in the world. DEPT® is committed to making a positive impact on the planet and since 2021 has been Climate Neutral and B Corporation certified. DIVERSITY, EQUITY & INCLUSION  At DEPT®, we take pride in creating an inclusive workplace where everyone has an equal opportunity to thrive. We actively seek to recruit, develop, nurture, and retain talented individuals from diverse backgrounds, with varying skills and perspectives. Not sure you meet all qualifications? Apply, and let us decide! Research shows that women and members of underrepresented groups tend not to apply for jobs when they think they may not meet every requirement, when in fact they do. We believe in giving everyone a fair chance to shine. We also encourage you to reach out to us and discuss any reasonable adjustments we can make to support you throughout the recruitment process and your time with us. Want to know more about our dedication to diversity, equity, and inclusion? Check out our efforts here.