Sr. Manager, Risk-Based Quality Management at Moderna

Espoo, Uusimaa, Finland -

Full Time

Start Date

Immediate

Expiry Date

24 Jan, 26

Salary

209400.0

Posted On

26 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Risk-Based Quality Management, Clinical Trial Execution, Monitoring Oversight, Risk Mitigation, Quality Trend Analysis, GCP Knowledge, Regulatory Guidelines, Quality Risk Management, CTMS Familiarity, EDC Familiarity, Centralized Monitoring, Effective Communication, Organizational Skills, Attention to Detail, Training and Onboarding, Collaboration

Industry

Biotechnology Research

Description

The Role: The Sr. Manager, Risk-Based Quality Management (RBQM) plays a critical cross-functional role in ensuring the quality and compliance of clinical trial execution through effective monitoring oversight and risk-based strategies. This role is responsible for overseeing site monitoring activities and co-monitoring efforts, as well as contributing to centralized monitoring, quality trend analysis, and risk mitigation initiatives. This individual may serve as the regional monitoring oversight lead for assigned programs, supporting internal teams and CROs in aligning operational execution with risk and quality expectations throughout the clinical trial lifecycle. Here’s What You’ll Do: RBQM Execution Support Support execution of RBQM strategies by contributing to study-level risk assessments and tracking mitigation activities. Monitor centralized risk data using tools and dashboards; escalate risk signals or operational trends for action planning. Assist in applying Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), and Key Performance Indicators (KPIs) across studies. Monitoring Oversight Coordination Serve as the regional or program-level point of contact for monitoring oversight, ensuring timely execution of co-monitoring visits, documentation, and reporting. Review monitoring reports and issue logs, providing guidance or retraining to CRO teams as needed. Conduct on-site or remote oversight visits and support site performance evaluation activities. Contribute to the development and implementation of Monitoring Oversight Plans, Clinical Monitoring Plans, and Vendor Oversight documentation. Identify performance or compliance trends and collaborate with clinical teams to implement corrective actions and quality improvement measures. Cross-Functional Support Collaborate with Clinical Operations, Data Management, R&D Quality, and CROs to ensure alignment between operational practices and RBQM principles. Assist with training and onboarding efforts related to RBQM tools and methodologies and monitoring oversight. Support the evaluation of new tools and dashboards that enhance centralized monitoring capabilities. Quality Monitoring & Improvement Track and report quality trends, site- and study-level risks, and operational findings to inform process improvements. Provide documentation and data during audits, inspections, and internal reviews, and assist study teams with follow-up actions. Contribute to fostering a quality- and compliance-oriented culture across study teams. Here’s What You’ll Need: Required Education, Experience, Certifications: Bachelor’s degree required in life sciences, healthcare, or related field or equivalent work experience required; Advanced degree preferred. A minimum of 7 years of clinical research, clinical operations or related experience, including at least 2 years of independent trial management, RBQM, or monitoring oversight experience. Working knowledge of GCP, regulatory guidelines, and quality risk management practices. Familiarity with CTMS, EDC, and centralized monitoring platforms. Effective communication and organizational skills with a strong attention to detail. Ability to travel up to 20%. Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future Location-specific perks and extras The salary range for this role is $130,800.00 - $209,400.00. 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. 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. 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. 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 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 leavesandaccommodations@modernatx.com. 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. #LI-TR2 - Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. 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 humanresources@modernatx.com 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. Return Home

Responsibilities

The Sr. Manager, Risk-Based Quality Management is responsible for overseeing site monitoring activities and contributing to risk mitigation initiatives. This role ensures alignment between operational execution and risk and quality expectations throughout the clinical trial lifecycle.