Sr. Manager, Technical Development Quality Assurance
3 weeks ago
The Role
Reporting to the Director of Technical Development Quality Assurance, the Sr. Manager Technical Development Quality Assurance will play a pivotal role in ensuring the quality and compliance of Modernas CMC development programs from early clinical stages through to commercialization. This individual contributor position involves closely working with the Technical Development teams to implement and maintain quality engagement that aligns with both internal and external phase-appropriate requirements.
Heres What Youll Do
Provide Quality Assurance oversight throughout the technical development phases of process development, as applicable, ensuring all activities comply with internal quality standards and best practices.
Evaluate and monitor the integration of quality assurance in the technical development processes to ensure end products are fit for purpose and meet predetermined quality specifications.
Collaborate on designing and executing robust quality systems that improve process reliability, ensuring consistent, high-quality outputs.
Work directly with the Technical Development teams to understand their quality needs and challenges. Assist in embedding quality assurance practices into daily operations and project workflows.
Establish key quality metrics for technical development projects to measure process efficiency, product consistency, and compliance with quality benchmarks.
Lead targeted quality improvement projects to address critical issues, enhancing system effectiveness and compliance.
Recommend and implement enhancements to quality systems and processes based on thorough analysis and collaboration with technical teams and Quality Systems business owners.
Lead quality assurance reviews and approvals of technical documentation, including protocols, reports, procedural documents, and risk assessments.
Verify quality data and approve development reports and process analytics, ensuring rigorous quality standards are maintained.
Facilitate cross-departmental initiatives to foster a culture of quality across the organization.
Develop and conduct training sessions for the Technical Development team and stakeholders, focusing on quality assurance best practices, new technologies, and continuous process improvements.
Partner with the Digital team to identify and implement digital tools and solutions that enhance process efficiencies and data management.
Ensure that quality planning is proactive, comprehensive, and aligned with the overall strategic goals of the organization.
Heres What Youll Bring to the Table (Preferred Qualifications)
Bachelors degree in a scientific/engineering discipline required with applied pharmaceutical industry experience of 5 years; 3 years with MS.
Proven experience in quality assurance, specifically within drug product development, clinical, and commercial phases of pharmaceutical products.
Demonstrated understanding of GxP regulations and quality management systems applicable to pharmaceutical development and manufacturing.
Experience with quality system design, implementation, and oversight in a pharmaceutical setting.
Exceptional written and oral communication and willingness to share knowledge and lessons learned.
Strong analytical and problem-solving skills to effectively address and ameliorate quality issues.
Excellent communication and interpersonal skills to effectively interact with cross-functional teams and facilitate training and development.
Ability to lead quality improvement initiatives and manage projects independently.
Proficient in data analysis and the use of digital tools to enhance quality processes.
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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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. 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Director of Technical Development Quality Assurance, the Sr. Manager Technical Development Quality Assurance will play a pivotal role in ensuring the quality and compliance of Modernas CMC development programs from early clinical stages through to commercialization. This individual contributor position involves closely working with...
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Norwood, Massachusetts, United States Moderna, Inc. Full timeThe RoleReporting to the Director of Technical Development Quality Assurance, the Sr. Manager Technical Development Quality Assurance will play a pivotal role in ensuring the quality and compliance of Modernas CMC development programs from early clinical stages through to commercialization. This individual contributor position involves closely working with...
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