Manager, RBQM

Moderna Therapeutics; Cambridge (MA); On-site; USD 109,200 - 174,600; Full time

Benefits offered by this job

Healthcare benefits

Mental health support

Family planning benefits

Paid time off

Savings plan

Location-specific perks

Job summary

Moderna is seeking a Manager of Risk-Based Quality Management (RBQM) to lead risk assessment, KRIs, QTLs, and integrated quality plans in clinical trials. You will collaborate with study teams, CROs, and Quality to ensure patient safety, data integrity, and regulatory compliance through RBQM principles.

This role involves central monitoring execution, data quality checks, UAT support, and ongoing process improvements. A strong background in RBQM and applicable systems is required.

Qualifications

• Bachelor’s degree or equivalent; life sciences preferred.
• 6+ years in clinical research or related field with RBQM exposure.
• Working knowledge of GCP, ICH E6(R2)/R3, and regulatory guidelines.
• Experience with CTMS, EDC, risk assessment tools, centralized monitoring platforms.
• Strong organizational, analytical, and communication skills.
• Proficiency with Microsoft Excel.
• Ability to travel up to 20%.

Responsibilities

• Support study- and program-level risk assessments and mitigation tracking.
• Develop and maintain the Integrated Quality Risk Management Plan.
• Contribute to CSR sections on Risk Management and QTLs with traceability.
• Maintain QTL definitions, parameters, and thresholds.
• Assist setup and review of centralized monitoring activities and KRIs.
• Contribute to monitoring plans, programming specs, and SDV plans.
• Perform data quality checks and support UAT and trend analysis.
• Assist investigations of risk signals and actions.
• Collaborate with teams to align RBQM strategies and oversight.
• Help maintain Monitoring Oversight Plans and track metrics.
• Review CRO/site monitoring reports and issue logs.
• Identify performance or compliance trends and support CAPAs.
• Support training and process improvement; maintain inspection readiness.
• Partner with cross-functional teams to promote quality-by-design.

Skills

RBQM

Cross-functional collaboration

Analytical skills

Microsoft Excel

Communication skills

Travel flexibility

Education

Bachelor’s degree or equivalent in life sciences/healthcare

Tools

CTMS

EDC

Centralized monitoring tools

CluePoints

Job description

The Role: The Manager, Risk-Based Quality Management (RBQM)

The Manager, Risk-Based Quality Management (RBQM) supports the execution and continuous improvement of risk-based approaches in clinical trial quality management. This role works cross-functionally to help ensure patient safety, data integrity, and compliance through effective implementation of RBQM principles, including risk management, central monitoring, and monitoring oversight. The Manager partners closely with study teams, CROs, and Quality functions to ensure RBQM activities are conducted according to defined processes, timelines, and regulatory expectations.

Here’s What You’ll Be Doing

Risk Management Support

• Support study- and program-level risk assessments, including identification of Critical to Quality (CTQ) factors, development of Quality Tolerance Limits (QTLs) and Key Risk Indicators (KRIs), and tracking of mitigation actions.
• Assist in developing and maintaining the Integrated Quality Risk Management Plan (IQRMP).
• Contribute to CSR sections related to Risk Management and QTLs, ensuring traceability and documentation accuracy.
• Maintain documentation for QTL definitions, parameters, and thresholds.

Central Monitoring Execution

• Participate in setup and review of centralized monitoring activities, including configuration and validation of KRIs, QTLs, and related reports in monitoring systems (e.g., CluePoints).
• Contribute to central monitoring plans, programming specifications, and SDV plans.
• Perform data quality checks, support User Acceptance Testing (UAT), and assist with initial data review and trend analysis.
• Support investigation and documentation of potential risk signals, trends, and associated actions.

Monitoring Oversight Support

• Collaborate with clinical and vendor teams to support execution of monitoring oversight activities in alignment with RBQM strategies.
• Help maintain Monitoring Oversight Plans and track monitoring metrics and issue trends.
• Assist in review of CRO and site monitoring reports, issue logs, and oversight documentation.
• Contribute to identification of performance or compliance trends and support implementation of corrective or preventive actions.

Continuous Improvement and Quality Culture Support

• Support training initiatives and contribute to process improvement efforts related to RBQM.
• Maintain documentation to ensure inspection readiness and contribute to audit preparation activities.
• Partner with cross-functional teams to reinforce a proactive, quality-by-design mindset.

Here’s What You’ll Need (Basic Qualifications)

• Bachelor’s degree or equivalent work experience required; degree in life sciences, healthcare, or a related field preferred.
• A minimum of 6 years of experience in clinical research, clinical operations or related field, including at least 1 year of exposure to risk management, centralized monitoring, or RBQM processes.
• Working knowledge of GCP, ICH E6(R2)/R3, and regulatory guidelines.
• Experience with clinical systems (CTMS, EDC, risk assessment tools, centralized monitoring platforms).
• Strong organizational, analytical, and communication skills.
• Proficiency with Microsoft Office (including Excel).
• Ability to travel up to 20%.

Pay & Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs.
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
• Savings and investments to help you plan for the future.
• Location-specific perks and extras.

The salary range for this role is $109,200.00 - $174,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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.

Our Working Model

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

Equal Opportunities

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 a place where everyone can grow.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 [e-mail].

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

Our Mission and Vision

Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.