Director, Manufacturing Plant Operations IT Head

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 make people smile by delivering breakthroughs 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, Massachusetts, and Ontario.

Summary:

As the Manufacturing Site IT Leader, your role will be to oversee and manage the IT operations at our new manufacturing site. You will be responsible for helping stand-up the new state of the art facility, ensuring smooth functioning of all IT systems and infrastructure, as well as driving digital transformation initiatives to optimize processes and enhance productivity. As a member of Site Leadership Team, the IT Head is also jointly responsible for the development of strategies, execution of these strategies as well as the overall performance of the site. IT Head must also be a role model for the KKNA Culture that will be engendered at the site.

Essential Functions:

• Help stand-up new plant, collaborating with cross-functional teams to ensure the right IT to enable operations

• Manage and maintain all IT systems and infrastructure at the manufacturing site

• Ensure the availability and reliability of IT services to support production operations

• Collaborate with cross-functional teams to identify and implement digital solutions to improve efficiency and streamline processes

• Lead and supervise a team of IT professionals, providing guidance and support

• Develop and implement IT policies and procedures to ensure compliance and data security

• Monitor and analyze IT performance metrics to identify areas for improvement and implement corrective actions

• Ensure compliance to regulatory requirements and BI / external standards (EHS, Corporate procedures, GxP etc.)

• Stay up-to-date with the latest technology trends and advancements in the pharma and manufacturing industry

• Develop the site IT strategy and planning in line with global manufacturing IT strategy and roadmap

• Collaborate with global manufacturing IT team to build and execute the integrated IT roadmap

• Manage vendor relationships and negotiate contracts for IT services and equipment

• Provide technical support and troubleshooting assistance to end-users

• Translate business requirements to technical requirements in support of project execution.

• Collaborate with global IT teams to align local IT strategies with corporate objectives.

Requirements:

Education

Bachelor's degree in Information Technology or a related field. Relevant certifications (e.g., ITIL, PMP) are a plus

Experience

At least 10 years' experience in a role supporting manufacturing plant and/or supply chain operations. 6+ years experience in Cloud Computing. Proven experience in IT leadership roles, preferably in a manufacturing and pharma environment. Excellent understanding of manufacturing operations and business processes for Pharma and clinical operations. Strong understanding and technical application of Good Manufacturing Practice (GMP) regulations and regulatory guidance for industry. Experience in driving digital transformation initiatives. Strong leadership and team management skills.. Knowledge of data security and compliance regulations. Experience working for international companies with multi-cultural background and diversified environment.. Working for Japan-based companies are a plus

Technical Skills

Proficient in MS Office Suite. Strong knowledge of Microsoft Dynamic 365 systems and processes. Strong knowledge across several IT disciplines including Network, Security, Infrastructure, and Manufacturing Systems. Strong understanding and process knowledge of Pharmaceutical Quality System. Strong knowledge of Veeva product suites for Pharma Manufacturing site. Ability to translate business requirements to technical requirements and needs

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.

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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.

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