Sr. Specialist, Quality Assurance, CSV
Moderna Therapeutics

Job Order #: 21079045

Cambridge, MA 02141

Full Time

40 hours per week

POSTED 7/6/2024

EXPIRES 9/29/2024

Job Description

The Role

In this role, this candidate will be responsible for cGMP compliance of computer system validation of process, facility, utilities, equipment, method and will be accountable for their execution in Moderna's Individualized Neoantigen Therapy program.

Here's What You'll Do

* Review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements

* Review validation documentation - such as user requirements, functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix requirements, deviations, validation summary reports, decommissioning reports and system use documentation (system admin, user admin procedures)

* Work with manufacturing/engineering to ensure necessary compliance controls are in place for computer system design changes/enhancement

* Responsible for QA oversight of the development and implementation of Quality, manufacturing, and laboratory systems/processes to facilitate new projects and continuous improvement activities

* Collaborate with global, cross-functional teams to accomplish company objectives and team goals, including but not limited to, on-time completion of system go-lives and enhancements

* With Manager support and guidance, identify and implement continuous improvement efforts for the computerized systems validation program to ensure alignment with regulatory regulations/guidance as well as Moderna mindsets

* Provide support for GxP regulatory inspections, as needed, including acting as subject matter expert for Quality GxP computer validation topics

* Monitor industry, new/revised regulations around CSV and guidance for impact to the organization related to computer system validation

* Review and approve deviations / OOS records and CAPAs

* Review and approve change control and IT/Digital Change Control records

* Review and approve Periodic Reviews for Computer Systems

* Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

* Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.

* Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

* Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Here's What You'll Need (Minimum Qualifications)

* Education: Bachelor's in science/Engineering

* Experience: B.S. degree (engineering or scientific discipline) with at 6+ years' experience OR Master's degree with 2-5 years' experience

Here's What You'll Bring to the Table (Preferred Qualifications)

* Experience in QA and/or Validation in the pharmaceutical industry.

* Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.

* A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

To view the full job description please use the link below.

How To Apply


320 Bent St.
Cambridge, MA 02141

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Moderna Therapeutics


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320 Bent St.
Cambridge, MA 02141