Job description

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
The Manager, Software Quality Assurance (SQA) will develop a variety of validation documentation for USDM clients to ensure implemented solutions meet regulatory requirements. The candidate should be able to develop and deliver an innovative validation approach and solutions to Life Science companies using various Enterprise Resource Planning (ERP)/Supply Chain Management (SCM) systems. The Manager, Software Quality Assurance will build a customer-focused relationship with client to identify business and compliance challenges and develop specifications and requirements to deliver the best validated SaaS solution that will be maintained by the USDM Cloud Compliance platform. As a consultant, this role will be responsible for tracking work hours by type of activity or project and maintaining full utilization (billable hours) as set by organization. Work is highly independent and may assume a team lead role for the validation team in each individual project. Additionally, this role will develop a roadmap for Packaging Solutions, technology, and Vendor/Partner Maturity to Support R&D innovation and customer solution maintenance.

Primary Responsibilities

• Work with clients to develop a validation plan to ensure that, at the end of the project, the system meets regulatory requirements.
• Work with client business functions and subject matter experts to develop User Requirements Specifications, Functional Requirements Specifications, and/or Design Specifications as required.
• Develop of test / validation scripts based on software design and configuration.
• Develop test protocols that thoroughly test business requirements.
• Develop Installation Qualification, Operation Qualification, and Performance Qualification scripts to test installation and configuration specifications as required.
• Knowledge of Automated Regression Testing would be ideal.
• Interact in a team environment, managing tasks and escalating issues as needed.
• Advise clients on assigning proper regulatory and business risk to computer systems and specifications.
• Advise clients on how to meet compliance requirements using a risk-based approach.
• Develop validation documentation and standard operating procedures for GxP applications.
• Provide test execution oversight and assist with deviation recommendations as required.
• May manage & coach project team members, as needed.
• May provide support for creating Statement of Work estimates and change orders.

Additional Responsibilities

• Identify and develop new solutions.
• Develop training on new solutions.
• Deliver new solutions.
• Prioritizes packaging solutions development and delivery.
• Develops key package deliverables.
• Review packaging documents.
• Provide input to the product and partner maturity for each Solution, and advice to BU and exec management to continue/discontinue offering or relationship with partner.

Qualifications

• Minimum of 3-5 years as a validation lead (Quality Consultant Lead).
• 10+ years of related experience in the pharmaceutical and/or medical device industry.
• Experience with validating QAD and one or more ERP SaaS Applications: Oracle Cloud, SAP-HANA, Dynamics, NetSuite.
• Knowledge of relevant rules and regulations, such as cGMP, GDP, GAMP 5, 21CFR Part11 and industry best practices as well as EudraLex and Annex 11 for European customers.
• Knowledge in any of the following areas: Product Life Cycle Management, Inventory Management, Manufacturing, Quality, or Supply Chain Management.
• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of computer systems.
• Fluent in Microsoft Office suite Including (Excel, Word, Power Point, Outlook).
• Excellent verbal and written communication and presentation skills.
• Ability to work effectively both independently and as part of a team.
• Ability to learn new technologies and processes quickly.
• Effective at executing tasks to accomplish objectives.
• Ability to identify and mitigate risks and to escalate when needed.
• Demonstrable team leadership, excellent judgment and decision-making skills, strong analytical and problem-solving skills, and critical thinking skills in order to deliver quality solutions to clients.
• Ability to work to tight deadlines and collaborate with the team to meet deadlines.
• Ability to mentor and lead others, self-motivated, able to work with minimal direction.
• Positive attitude and strong work ethic.

Education & Certifications

• University certificate or bachelor’s degree.
• Supply Chain, Quality, Cloud, or SaaS Certification preferred.

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.

Job Type: Full-time

Pay: $150,000.00 - $170,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Compensation package:

• Bonus pay

Experience level:

• 10 years

Schedule:

• Monday to Friday

COVID-19 considerations:
This role is 100% remote

Experience:

• GxP: 10 years (Required)
• Test automation: 5 years (Required)
• SaaS: 5 years (Required)

Work Location: Remote

colinoncars.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, colinoncars.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, colinoncars.com is the ideal place to find your next job.