Sr. Compliance Systems Engineer
Reporting to the Senior Director of GXP Systems, the Sr. Compliance Systems Engineer will lead the design, development, implementation and technical support of the Quality Management, Document Management and Learning Management systems. This position will be play a key role in deploying systems and integrated processes to support the overall digital / IT QA compliance systems landscape at Moderna.
Here's What You'll Do:
- Design and deploy technology to support the next generation Quality Management System
- Lead project delivery, coordinating multiple vendors and aligning cross-functional projects
- Develop and implement compliance data reports / outputs and contribute to the digital data strategy
- Support issue resolution, continuous process improvements and routine system updates of Veeva Quality Vaults, Veeva RIM and SuccessFactors LMS
- Define requirements and assist with technical design of integrations between compliance systems other GXP systems including ERP, LIMS and MES
- Assist with the creation of GMP computer system deliverables including user requirements, system specifications and validation test scripts
- Partner with Quality Assurance to assist with development of procedures and processes to ensure efficient usage and maintenance of technology
Here's What You'll Bring to the Table:
- A Bachelor degree in science, technology or another relevant academic discipline.
- 5-8 years of experience implementing and maintaining technology to support QA compliance
- Understanding of industry technology trends in quality management, document management and learning management
- Experience with Veeva Quality and Submissions Vaults, QMS (Veeva, TrackWise, etc) and SuccessFactors learning management
- Expertise with computer systems validation practices (GAMP)
- Familiarity with data report development and systems integration is a plus
Here's What We'll Bring to the Table:
- Daily on-site catered lunches.
- Company-provided iPhone.
- Free parking, monthly subway pass or a subsidized commuter rail pass.
- Highly competitive healthcare coverage. Including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP.
- Flexible Spending Accounts for medical expenses and dependent care expenses.
- 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately.
- A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability.
- Voluntary legal assistance plan.
- 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays.
- Adoption assistance, competitive parental leave, discount to local childcare centers, as well as access to Care.com.
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.