In this role, you will be responsible for the delivery of software solutions and administration of the electronic Validation Management Systems. The role will be accountable for project delivery, key technical activities such as configuration/customization of system, and compliance and operational support. This is an exciting opportunity to influence the direction of the digital vision of the company as we build world class digital systems to further our mission of delivering transformational mRNA medicine to patients. Moderna is a cloud-first company, and this role will balance building strong foundations, with implementing innovative new solutions that drive business value. With our progress towards commercialization, this position will play a key role partnering with our business stakeholders to enable our systems and processes for long term success.
Heres What Youll Do
Define functional solutions, determine, and perform configuration / programs and develop data strategy
Lead technical projects focusing on expanding capabilities of the electronic validation management system
Perform evaluation and prioritization of system enhancements and capabilities to ensure efficient usage and maintenance
Evaluate functional configuration issues and provides advanced support on issue resolution
Provide administrator support to operate systems including role management, access management and data management
Perform a review of design and requirement specifications to establish fit-for-purpose for systems
Provide technical design insight within the applications, maintain, and improve data model and integrations between systems including EDMS and MES
Participate in validation activities related to implementation and on-going support
Generate standard and custom reports based on business and compliance needs
Support /perform system risk assessments and testing quarterly or yearly to support vendor software releases and patches
Support planned and unplanned inspections/audits
Heres What Youll Need (Minimum Qualifications)
Bachelors degree in science, technology, or another relevant academic discipline
6+ years of experience implementing and maintaining technology to support compliance processes in a regulated biotech or Pharma company
Experience with electronic validation management systems (Kneat) or similar technologies
Experience with validation policies and documentation for various systems and processes
Prior working experience with computer systems validation practices (GAMP)
Heres What Youll Bring to the Table (Preferred Qualifications)
Excellent interpersonal and communication skills with ability to work collaboratively within a team of cross functional stakeholders to influence decisions
Quality orientated with strong attention toward detail
Self-directed with effective analytical and problem-solving skills. Must be able to drive results on multiple complex assignments simultaneously in a fast-paced environment
Understanding of industry technology trends in document management and validation management.
Knowledge of minimal protocol requirements and ability to author various life cycle documents associated with C&Q and Validation
API, data report development and systems integration
Working knowledge of relevant FDA, EU, ICH guidelines and regulations related to computer system validation and data integrity
Technical writing skills required
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!
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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. Were 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at firstname.lastname@example.org. (EEO/AAP Employer)