Moderna
Sr. Manager, Combination Product Quality
Moderna, Norwood, Massachusetts, us, 02062
The Role
Located in Norwood, MA and reporting to the Director, Technical Development Quality Assurance, the
Senior
Manager, Combination Product Quality
will be responsible for quality oversight of design control and risk management activities for combination products and medical devices in development and on-market products to ensure alignment with current regulatory expectations for combination products and medical devices.
In collaboration with the device development teams and medical device suppliers and testing partners, this individual will support development, implementation, and continuous improvement of Moderna's products. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.
Here's What You'll DoProvide guidance and make Quality decisions on Combination product development and regulatory strategies. Proactively support design control activities as governed by project plan
Lead Quality review and approval of all technical documentation for device development technical and risk management documentation including planning, traceability matrix, protocols and reports, and risk assessments
Support design-related continuous improvement efforts, design changes, and market expansions.
Support post market surveillance activities including complaint management and medical device and vigilance reporting.
Act as global Quality representative in cross-functional forums to provide support and oversight to internal and external manufacturing and testing facilities for application of the device and combination products, Global policies, SOPs, and Standards throughout the lifecycle of products.
Provide technical quality support in development and on-market products through supporting root cause investigations, and incident management (Deviations/CAPAs) across Moderna's internal and external manufacturing and testing sites
In collaboration with Quality System business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement initiatives of the Global Quality Management System
In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve efficiencies of processes
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.
Here's What You'll Bring to the Table (Preferred Qualifications)
Bachelor's degree, preferably in Sciences or Engineering with applied Quality industry experience of 5 years; 3 with MS.
Mastery of relevant FDA, EU regulations, ICH standards/guidelines, and ISO requirements, and experience in supporting successful regulatory inspections.
Experience in Combo product/s development, experience in medical device as QA engineer is a plus.
Experience in working with CMO/CLO for process validation and product testing.
Ability to interact effectively with all levels of personnel within the organization.
Strong scientifically with technical expertise to ensure robust analysis of complex device product data and the ability to use that information to make scientifically sound Quality risk-based recommendations.
Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
Outstanding communication skills (verbal and written).
Ability to navigate through ambiguity and rapid growth and adapt to change.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
A 'digital first' and curious mindset that allows you to constantly learn and challenge the status quo.
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 parents401k 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, 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)
Located in Norwood, MA and reporting to the Director, Technical Development Quality Assurance, the
Senior
Manager, Combination Product Quality
will be responsible for quality oversight of design control and risk management activities for combination products and medical devices in development and on-market products to ensure alignment with current regulatory expectations for combination products and medical devices.
In collaboration with the device development teams and medical device suppliers and testing partners, this individual will support development, implementation, and continuous improvement of Moderna's products. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.
Here's What You'll DoProvide guidance and make Quality decisions on Combination product development and regulatory strategies. Proactively support design control activities as governed by project plan
Lead Quality review and approval of all technical documentation for device development technical and risk management documentation including planning, traceability matrix, protocols and reports, and risk assessments
Support design-related continuous improvement efforts, design changes, and market expansions.
Support post market surveillance activities including complaint management and medical device and vigilance reporting.
Act as global Quality representative in cross-functional forums to provide support and oversight to internal and external manufacturing and testing facilities for application of the device and combination products, Global policies, SOPs, and Standards throughout the lifecycle of products.
Provide technical quality support in development and on-market products through supporting root cause investigations, and incident management (Deviations/CAPAs) across Moderna's internal and external manufacturing and testing sites
In collaboration with Quality System business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement initiatives of the Global Quality Management System
In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve efficiencies of processes
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.
Here's What You'll Bring to the Table (Preferred Qualifications)
Bachelor's degree, preferably in Sciences or Engineering with applied Quality industry experience of 5 years; 3 with MS.
Mastery of relevant FDA, EU regulations, ICH standards/guidelines, and ISO requirements, and experience in supporting successful regulatory inspections.
Experience in Combo product/s development, experience in medical device as QA engineer is a plus.
Experience in working with CMO/CLO for process validation and product testing.
Ability to interact effectively with all levels of personnel within the organization.
Strong scientifically with technical expertise to ensure robust analysis of complex device product data and the ability to use that information to make scientifically sound Quality risk-based recommendations.
Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.
Outstanding communication skills (verbal and written).
Ability to navigate through ambiguity and rapid growth and adapt to change.
Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.
A 'digital first' and curious mindset that allows you to constantly learn and challenge the status quo.
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 parents401k 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, 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)