In this role, you will support the Records Management and Knowledge Management will be responsible for maintaining documents in compliance with business needs and regulatory expectations. The individual will be responsible for formatting and administration of paper-based and electronic document workflows. Additionally, this individual will be responsible for leading and managing the training program for the Marlborough INT site. This individual should possess excellent organizational skills, the ability to work independently on multiple tasks, and the ability to work in a fast-paced environment are required.
Here's What You'll Do
Manage an effective GMP training program within the site to ensure employees are fully aware of GMP expectations and requirements and effectively demonstrate this awareness as part of their core competencies.
Create and track Training metrics/reports to measure training effectiveness and accountable for escalation of training quality system issues.
Collaborate with clinical GMP area managers to analyze needs and develop, implement, and measure effectiveness of training and work with individual department leads to develop job specific training matrices.
Oversee the management of cGMP training files in the electronic document management system.
Provide support and oversight of course development, training structure, and design across the site.
Organize and present live and virtual training sessions to groups and individuals (e.g., annual GMP)
Support cross functional teams in processing document requests, document approval, and document archival.
Business administration tasks within eDMS.
Assist in document control process improvements with Document Types, Lifecycles, and Workflows in eDMS.
Maintain periodic review process for documents.
Collaborate with cross-functional teams to identify efficiencies around maintenance/control of paper-based documents.
Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.
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.
Additional duties as may be assigned from time to time
Here's What You'll Need ( Basic Qualifications)
Education: Bachelor's or Master's degree, preferably in Sciences or Engineering
Experience: BS/BA with 4+ years of biotech or pharma experience, MS with 3+ years' experience.
REQUIRED LICENSES, CERTIFICATIONS, COURSES
Here's What You'll Bring to the Table (Preferred Qualifications)
Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP, GLP, GCP, GVP or other applicable standards).
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work.
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)
