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 sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you 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 to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

USDM is looking for an experienced Sr. Validation Lead to join our team. The successful candidate will lead compliance initiatives for USDM clients. This may include developing the validation documentation listed below or managing a team to develop the deliverables.

Primary Responsibilities

• The Validation Lead will develop customer validation documents, including VP, URS, IOPQ, TM, PQ and VSR. Additionally, Validation Lead will be responsible for drafting customer Administration and End-User SOPs.
• Advising clients on assigning proper risk to computer systems.
• Advising clients on how to meet compliance requirements using a risk-based approach.
  • Provide test execution oversight and assist with deviation recommendations as required.
  • Develop validation documentation and standard operating procedures for various GxP applications.
  • Develop test protocols that thoroughly test business requirements.
• Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA 21 CFR Part 11 requirements.
• Work with client business functions and subject matter experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required
• Develop Installation Qualification scripts, Operation Qualification scripts to test functional requirements, and Performance Qualification scripts to test user requirements as required.

Additional Responsibilities

• Manage tasks based on aggressive timelines.
• Interact with customers at multiple sites.

Qualifications

• A minimum of 5 years in pharmaceutical industry, focusing on Computer Systems Validation.
• Experience with early stage, pre-commercial companies preferred.
• Experience juggling multiple short-term projects.
• Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
• Expertise in use and validation of GMP cloud applications, with specific expertise with Veeva (all modules – QualityDocs, Training, QMS, RIM, eTMF etc.)
• Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance.
• Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Smartsheets and Salesforce
• Ability to work independently.

Education & Certifications

• Bachelor's degree in Technology, Engineering, or related field required.

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.
• Travel to client site for onsite work as needed.

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

Salary/Hourly Rate Range (W2): 125,000 - 160,000 USD

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 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: https://usdm.com/careers