About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you will have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown into a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
We are seeking an ERP Validation Lead to support complex technical ERP projects and business matters.
Primary Responsibilities
- Develop and deliver innovative GxP validation approach and solutions to Life Science companies using ERP Systems like SAP R/3, SAP S/4HANA, Oracle Cloud SCM, NetSuite, QAD and other technologies in Enterprise Resource Planning (ERP)/Supply Chain & Manufacturing (SCM) and/or Product Lifecycle Management (PLM).
- Build a customer-focused relationship with clients to identify business and compliance challenges and develop specifications and requirements to deliver the best validated solutions.
- Prepares protocols and reports for validation work.
- Coordinates all validation activities by constant communication with affected departments and personnel (USDM, client and System Integrator).
- Oversees and reviews validation area processes and procedures.
- Drive working sessions with client to ensure expectations and direction are aligned and timelines are being met.
- Create proposals and Statements of Work (SOW's), as well as responding to Request for Proposals (RFP's).
- Collaborate with proposal team, sales and legal to estimate, plan, mobilize and execute project.
- Co-present proposals to clients. Identify additional product/service opportunities.
Additional Responsibilities
- May train / mentor junior staff as needed.
- Additional tasks as needed.
Qualifications
- A minimum of 6 years' experience in ERP Validation, with a focus on GxP compliance.
- ERP Systems experience can be on prem solutions like SAP R/3 or Oracle EBS or Cloud SaaS solutions like Oracle Cloud SCM, Oracle Cloud PLM, and SAP 4/HANA.
- Experience with validating one or more ERP Applications: SAP (MM, SCM, QM, AMS) or Oracle EBS (INV, QA, ERES) or Oracle Cloud (INV, PLM, SCM, ERES) and other related ERP applications.
- Knowledge of Automated Regression Testing preferred.
Education & Certifications
- Bachelors degree in Technology, Engineering, or related field.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
- Operate other office productivity machinery, such as a calculator, scanner, or printer.
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the 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. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Compensation
W2 candidates only.
Salary/Hourly Rate Range (W2): USD 131000 - 160000.
The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.
Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.
All employees are eligible for USDM's rewards and recognition program.
For more details about our benefits, visit us here:
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