Lab Software Validation and Support Leader

3 weeks ago


Exton, Pennsylvania, United States Frontage Laboratories Full time
Job Summary: Frontage Laboratories is seeking a Lab Software Validation and Support Leader to join our team. As a key member of our computer system validation program, you will provide leadership and support for software applications across multiple sites. Your primary responsibilities will include defining and maintaining the validation program, ensuring compliance with regulatory requirements, and managing a team of professionals responsible for software application implementation, validation, and maintenance.

About the Role:
This is an excellent opportunity to work with a leading contract research organization and contribute to the success of our clients. As a Lab Software Validation and Support Leader, you will have the chance to develop and implement a comprehensive computer system validation program, collaborate with cross-functional teams to identify and implement technology improvements, and communicate effectively with stakeholders to ensure seamless integration of new technologies.

Responsibilities:
  • Define and maintain the computer system validation program to ensure compliance with GxP regulations
  • Provide leadership and support for software applications across multiple sites
  • Manage a team of professionals responsible for software application implementation, validation, and maintenance
  • Collaborate with cross-functional teams to identify and implement technology improvements
  • Maintain accurate records of software changes and upgrades

Requirements:
To be successful in this role, you will need a Bachelor's degree in a relevant scientific, engineering, or computer-based field, along with at least 10 years of experience in the pharmaceutical industry or equivalent combination of education and IT and/or lab experience. You should have a strong understanding of GxP regulatory requirements, computerized analytical systems, and data integrity. Additionally, expertise in lab systems, such as Watson LIMS, IDBS eNotebook, and Microsoft Office Applications, is essential.

Salary and Benefits:
We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience, plus a comprehensive benefits package, including health insurance, 401(k) plan, disability insurance, and life insurance.

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