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Sr. Specialist, Quality Assurance, CSV

2 months ago

Marlborough, United States Moderna Full time

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.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

Highly competitive and inclusive medical, dental and vision coverage options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ+ community Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • Discretionary year-end shutdown • Paid sabbatical after 5 years; every 3 years thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes Location-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer) #J-18808-Ljbffr