In this role, you will be responsible for overseeing the management and maintenance of our GxP documentation and records system and processes across our global GxP organization.
Here's What You'll Do
Leadership and Strategy:
Maintain and continuously improve our comprehensive global strategy for GxP documentation and records management, ensuring compliance with regulatory requirements and industry best practices reflected in the relevant policies, procedures, and associated documentation.
Provide strategic direction and guidance to global and local teams supporting document control, records management and archival as well as cross-functional teams on document control, document lifecycle management, and records management processes.
Engage with Digital Business Partners to establish a cohesive roadmap supporting the compliance and dynamic business needs of the electronic document management system.
Act as the Quality Systems Document Control and Records management Subject Matter expert for internal stakeholders and in support of third party audit and external health authority inspections.
Develop appropriate metrics to monitor the health of systems and processes.
Identify and assign appropriate deputies to support business in times of absence.
Set clear goals, objectives, and expectations for team members and monitor execution.
Provide guidance and direction to employees in alignment with organizational strategies and priorities.
Inspire and motivate team members to achieve their full potential.
Establish succession plan(s) and employee development plans to support them.
Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.
GxP Documentation Management:
Oversee the creation, review, approval, and revision of GxP documents, including Standard Operating Procedures (SOPs), protocols, batch records, and other controlled documents.
Ensure document control procedures are in place and followed, maintaining the accuracy, integrity, and availability of GxP documents.
Collaborate with stakeholders to establish and maintain document templates, formatting standards, and version control systems.
Records Management:
Maintain and improve the global records management program, including the classification, retention, and disposition of GxP records in compliance with regulatory requirements throughout the complete document lifecycle including chain of custody and associated data integrity.
Establish procedures for the identification, capture, and indexing of records, ensuring easy retrieval and accessibility.
Manage controls for long term storage and required retention periods.
Stay up to date with evolving regulatory requirements and industry trends related to records management and implement necessary changes to maintain compliance.
Training and Compliance:
Develop and deliver training programs on GxP documentation and records management to ensure employees understand and adhere to relevant procedures and guidelines.
Oversee the periodic review process of controlled documents and related content.
Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
Continuous Improvement:
Identify opportunities for process improvement and automation in GxP documentation and records management, leveraging technology solutions and machine learning capabilities.
Lead or participate in cross-functional initiatives to enhance efficiency, accuracy, and compliance in document and records management practices.
Additional duties as may be assigned from time to time
Here's What You'll Need ( Basic Qualifications)
Education: Bachelor's degree in a scientific or related field.
Experience: Minimum of 8 years of experience in GxP document control and records management within the pharmaceutical, biotechnology, or related industry.
Here's What You'll Bring to the Table (Preferred Qualifications)
Strong knowledge of global regulatory requirements (FDA, EMA, ICH) and industry standards related to GxP documentation and records management.
Proven experience in leading and managing teams, with excellent leadership and interpersonal skills.
Familiarity with electronic document management systems (e.g., Veeva QualityDocs) and records management software.
Strong attention to detail, organizational skills, and ability to prioritize and manage multiple projects simultaneously.
Excellent written and verbal communication skills, with the ability to effectively collaborate and communicate with stakeholders at all levels of the organization.
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)
