Manager, ICT Delivery
Kyowa Kirin, Inc.- U.S. · Princeton, NJ · 2 mo ago
Manufacturing$121k–$157k/yrFull-time
Essential Functions
- Participate in project planning, execution, risk management, and quality assurance across multiple concurrent initiatives.
- Ensure solutions meet regulatory and data privacy requirements, including GxP, 21 CFR Part 11, HIPPA, GDPR and data integrity standards.
- Apply and follow appropriate delivery methodologies (Agile, Waterfall, hybrid) based on project needs and compliance considerations.
- Collaborate with business, technical teams and vendors to ensure accurate translation of business requirements into technical solutions.
- Assume accountability throughout all phases of system development lifecycle from ideation and planning through production support and troubleshooting.
Additional Activities
- IT Project Oversight - Review project timelines, milestones, risks and budget to ensure delivery stays on track.
- Stakeholder Communication & Alignment - Manage expectations, clarify priorities and drive compromise between business needs and technical constraints.
- SDLC Compliance – Ensure all system changes follow appropriate lifecycle processes; review documentation for accuracy, completeness, and audit readiness.
- Issue Resolution & Operational Support – Assist in the triage of issues / incidents that impact production systems or project timelines.
Requirements
- Education: Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required.
- Experience: At least 5 years’ experience delivering IT projects within a regulated industry, ideally pharmaceuticals or life sciences; Familiarity with multiple functional domains (e.g. Quality, Regulatory, Medical, Commercial and/or Clinical); Knowledge of GxP compliance, validation practices and regulated system requirements; Experience with large-scale, global implementations; Experience with enterprise technologies such as Veeva Vault, Salesforce.com, Microsoft Dynamics.
- Technical Skills: Proficient in MS Office Suite.
Working Conditions
- Requires up to 10% domestic and international travel.
Pay & Benefits
The anticipated salary for this position will be $121,000 to $156,800. 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).
Kyowa Kirin North America provides 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