Biotech & Pharma TN Sponsorship Jobs in New Jersey

JOB SUMMARY

The Manager, IT Solution Delivery is a hands-on technical role focused on the design, implementation, integration, and support of critical TechOps and GxP systems. This role is responsible for end-to-end system ownership across LIMS (Stability Module and QC Module), Track & Trace applications, and other regulated QC/QA applications, including system configuration, integration, validation, and operational support. The ideal candidate brings strong expertise in GxP-compliant systems engineering, including 21 CFR Part 11 / Annex 11 compliance, data integrity, and computer system validation (CSV). This position is highly execution-focused, requiring direct involvement in system configuration, troubleshooting, data migration, integrations, and release management.

At Otsuka, we defy limitations, so that others can too. We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day. We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

JOB DESCRIPTION

The Solution Delivery Partner will collaborate with IT Business Partners to assess and drive recommendations for the adoption of technology solutions that achieve business operational outcomes and strategic goals. The Solution Delivery will coordinate across various shared services groups within IT and other functions to successfully analyze, align, integrate, document, and enable new capabilities for Otsuka and its affiliates.

CORE RESPONSIBILITIES

- Act as the technical owner for TechOps applications including LabWare LIMS, LabVantage, UniTrace, Specification Management Systems, GlobalVision, and SLIMStat, ensuring system stability, performance, and compliance.
- Demonstrate and apply insights and knowledge of leading technology trends and best practices to improve processes and support business decision-making.
- Execute the successful delivery of new capabilities using robust Software Development Life Cycle (SDLC) practices.
- Ensure all computerized systems and applications adhere to FDA and GxP regulations, with a focus on data integrity and compliance standards within the pharmaceutical industry.
- Maintain strong working knowledge of DSCSA requirements and their impact on serialization, EPCIS data exchange, and end-to-end track-and-trace processes across manufacturing, packaging, and supply chain operations.
- Serve as a liaison between business stakeholders and technical teams, translating business requirements into effective technical solutions.
- Participate in system implementation activities, including configuration, integration, testing, validation, deployment, and ongoing support.
- Support continuous improvement initiatives to enhance system reliability, compliance, and operational efficiency.

QUALIFICATIONS

7+ years of IT experience, including 4+ years of Life Sciences or regulated industry experience in a technical support, development, systems administration, or service delivery role. Strong understanding of technology trends and industry best practices that improve business processes and solution delivery effectiveness. Experience working with globally distributed business and IT teams, including stakeholders in Japan, Europe, and India. Working knowledge and hands-on experience with GxP Life Sciences platforms, including LabWare LIMS, LabVantage LIMS, UniTrace (Serialization/Traceability), and other regulated QC/QA systems. Experience with application configuration, system administration, API-based and file-based integrations, data migration, and validation activities in regulated environments. Proficiency in SQL (Oracle, SQL Server, PostgreSQL) and scripting/tools such as Python, SSIS, Groovy, and JavaScript. Knowledge of Computer System Validation (CSV), 21 CFR Part 11, Annex 11, and data integrity principles preferred. Strong analytical, troubleshooting, communication, and stakeholder management skills.

EDUCATIONAL QUALIFICATIONS

Bachelor’s degree in Computer Science, Engineering, Information Systems, or a related field. Advanced degree in Science, Business Administration, Pharmaceutical Sciences, or a related discipline is preferred.

COMPETENCIES

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

COMPENSATION

- Minimum $121,103.00 - Maximum $181,125.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

APPLICATION DEADLINE

This will be posted for a minimum of 5 business days.

COMPANY BENEFITS

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.

STATEMENT REGARDING JOB RECRUITING FRAUD SCAMS

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.