BioSpace, Inc.
Senior Manager, Inspection Management
BioSpace, Inc., Cambridge, Massachusetts, us, 02140
Job Details
The Role
In this role, you will primarily focus on Regulatory Health Authority inspection readiness, planning, logistics, and supporting inspections, ensuring compliance with Health Authority Regulations (e.g., FDA, EMA, etc.) and will be responsible for conducting Regulatory Authority pre-inspection, during inspection and post-inspection activities across R&D. The appointee will also support regulatory intelligence activities, partner with local R&D functions and study teams to create a quality culture within Moderna and help reach a sustained state of inspection readiness
Here's What Youll Do:Builds and maintains strong and productive relationships with key stakeholders within R&D to support the successful and compliant execution of Moderna regulatory inspection activities.Maintains in-depth knowledge of governmental regulations affecting GCP, GVP, GLP in the drug development process.Plan, and coordinate GCP, GVP, GLP, GCLP regulatory authority inspections (routine, directed or submission driven) and the pre-inspection request process.Coordinate and manage both inspection readiness and preparation activities such as inspection management trainings, mock inspection interviews, mock inspections, site risk assessments and clinical site inspection preparation visits in preparation for regulatory authority inspections.Provide guidance and direction in development of responses to observations resulting from inspections of Modernas R&D programs.Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.Lead and manage post-inspection lessons learned sessions, ensuring all actions are tracked to completion.Contributes to and maintains inspection management plans, trainings, and strategies for the R&D Quality inspection management program.Review and provide input into study team inspection preparation activities, storyboards, etc.Collaborates with industry through benchmarking of regulatory activities that may influence regulatory inspection activities and strategies.Contribute to the ongoing operations of the R&D Quality Regulatory Intelligence Program in issuance of multi-discipline monthly briefing reports to the organization.Provide input into the issue management program to ensure early detection of issues, development of appropriate and robust corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness is attained.Support RDQ projects and initiatives, as assignedProvides mentoring for new and junior staff members, as assignedContribute to the continuing development of a quality culture at ModernaHeres What Youll Need (Minimum Qualifications)
BS/BA, MS or PhD and a minimum of 10, 8, 6 years experience, respectively, in Biotech, Pharma or Clinical Research Organization.Heres What Youll Bring to the Table (Preferred Qualifications)
Knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GxP regulations, guidelines and local legislation.Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.Experience with inspection coordination and logistical planning for regulatory authority inspections.Strong communication and presentation skills, both verbal and written.Experience developing responses to regulatory authority inspection findings.Experience working with CROs, vendors, and relationship management.Leadership skills with ability to effectively organize and execute tasksAbility to work both independently and in a team environment.Strong analytical, problem solving and decision-making skills in a complex, fast-paced, and changing environment.Ability to collaborate effectively in a dynamic, cross-functional matrix environment.Ability to influence and negotiate effective solutions, excellent interpersonal skills.A desire to make an impact as part of a high-growth, transformational company that is
Bold, Relentless, Curious, and Collaborative.Travel Requirements
Travel of up to 30% requiredModerna 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 holidaysVolunteer time to participate within your communityDiscretionary year-end shutdownPaid 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, 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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The Role
In this role, you will primarily focus on Regulatory Health Authority inspection readiness, planning, logistics, and supporting inspections, ensuring compliance with Health Authority Regulations (e.g., FDA, EMA, etc.) and will be responsible for conducting Regulatory Authority pre-inspection, during inspection and post-inspection activities across R&D. The appointee will also support regulatory intelligence activities, partner with local R&D functions and study teams to create a quality culture within Moderna and help reach a sustained state of inspection readiness
Here's What Youll Do:Builds and maintains strong and productive relationships with key stakeholders within R&D to support the successful and compliant execution of Moderna regulatory inspection activities.Maintains in-depth knowledge of governmental regulations affecting GCP, GVP, GLP in the drug development process.Plan, and coordinate GCP, GVP, GLP, GCLP regulatory authority inspections (routine, directed or submission driven) and the pre-inspection request process.Coordinate and manage both inspection readiness and preparation activities such as inspection management trainings, mock inspection interviews, mock inspections, site risk assessments and clinical site inspection preparation visits in preparation for regulatory authority inspections.Provide guidance and direction in development of responses to observations resulting from inspections of Modernas R&D programs.Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.Lead and manage post-inspection lessons learned sessions, ensuring all actions are tracked to completion.Contributes to and maintains inspection management plans, trainings, and strategies for the R&D Quality inspection management program.Review and provide input into study team inspection preparation activities, storyboards, etc.Collaborates with industry through benchmarking of regulatory activities that may influence regulatory inspection activities and strategies.Contribute to the ongoing operations of the R&D Quality Regulatory Intelligence Program in issuance of multi-discipline monthly briefing reports to the organization.Provide input into the issue management program to ensure early detection of issues, development of appropriate and robust corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness is attained.Support RDQ projects and initiatives, as assignedProvides mentoring for new and junior staff members, as assignedContribute to the continuing development of a quality culture at ModernaHeres What Youll Need (Minimum Qualifications)
BS/BA, MS or PhD and a minimum of 10, 8, 6 years experience, respectively, in Biotech, Pharma or Clinical Research Organization.Heres What Youll Bring to the Table (Preferred Qualifications)
Knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GxP regulations, guidelines and local legislation.Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.Experience with inspection coordination and logistical planning for regulatory authority inspections.Strong communication and presentation skills, both verbal and written.Experience developing responses to regulatory authority inspection findings.Experience working with CROs, vendors, and relationship management.Leadership skills with ability to effectively organize and execute tasksAbility to work both independently and in a team environment.Strong analytical, problem solving and decision-making skills in a complex, fast-paced, and changing environment.Ability to collaborate effectively in a dynamic, cross-functional matrix environment.Ability to influence and negotiate effective solutions, excellent interpersonal skills.A desire to make an impact as part of a high-growth, transformational company that is
Bold, Relentless, Curious, and Collaborative.Travel Requirements
Travel of up to 30% requiredModerna 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 holidaysVolunteer time to participate within your communityDiscretionary year-end shutdownPaid 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, 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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