BioSpace, Inc.
Associate Director, PV Quality
BioSpace, Inc., Cambridge, Massachusetts, us, 02140
Job Details
The Role
In this role, you will provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers, provide compliance support to the Moderna PV organization, establish and maintain a robust global audit program for PV, and assist in managing Regulatory Authority inspections of Modernas PV system. Additionally, the Associate Director, PV Quality will lead the development of PV Annual Audit Plans. The Associate Director, PV Quality partners with the CSPV, GRS and other functional area organizations to create a quality culture within Moderna and drive toward a sustained state of inspection readiness.
This leadership role, under the direction of the Senior Director, RDQ will provide support for junior staff members and mentorship within the RDQ PV function. The Associate Director, PV Quality plays a key role in promoting a quality culture that ensures sustained compliance to global, national and local regulations.
Heres What Youll DoParticipate in the development of quality and compliance strategies for the support of global pharmacovigilance activities.Work closely with the Moderna Global Pharmacovigilance and R&D Quality & Compliance (RDQ&C) Process Excellence and Training to support development of R&D policies and procedures related to PV activities.Partner closely with member of Global Pharmacovigilance and the QPPV to support the successful and compliant execution of Moderna PV activities.Conduct and report audits of Modernas Pharmacovigilance System, including but not limited to audits of PV processes, systems, vendors, and affiliates.Follow-up on CAPAs resulting from audit findings identified during PV audits to ensure effective remediation.Develop and maintain Annual Audit Plans for the RDQ&C GVP audit program.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.Actively participate as a key member of the inspection team for inspections of Modernas pharmacovigilance system, including RDQ Inspection Host and participate, as needed in PV Regulatory Authority inspections.Provide strategic input in the development of responses to Regulatory Authority inspection findings for inspections of Modernas PV system.Participate in Regulatory Authority inspection and provide input and review of responses to inspection observations and regulatory agency questions resulting from inspections .Contribute to the continuing development of a quality culture at Moderna.Travel, including international up to 35%.Additional duties as may be assigned from time to timeHeres What Youll Need (Minimum Qualifications)
BS/BA, MS or PhD / PharmD and a minimum of 10, 8, 6 years experience, respectively, in Biotech, Pharma or Clinical Research Organization.Audit certification (e.g., ASQ Lead Auditor) preferred.This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.Heres What Youll Bring to the Table (Preferred Qualifications)
Strong knowledge of relevant global guidelines and applicable GVP regulations, guidelines and local legislation.Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.Experience working with CROs, vendors, and relationship management.Strong interpersonal skills and ability to interact effectively with all levels within the organization.Leadership skills to provide training, mentoring, and managing quality professionals.Experience leading / hosting regulatory authority inspections and developing responses to regulatory authority inspection findings.Ability to solve complex problems taking a broad perspective to identify innovative solutions.Ability to manage multiple projects in a fast-paced environment.Ability to collaborate and influence effectively in a dynamic, cross-functional matrix environment.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 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 provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers, provide compliance support to the Moderna PV organization, establish and maintain a robust global audit program for PV, and assist in managing Regulatory Authority inspections of Modernas PV system. Additionally, the Associate Director, PV Quality will lead the development of PV Annual Audit Plans. The Associate Director, PV Quality partners with the CSPV, GRS and other functional area organizations to create a quality culture within Moderna and drive toward a sustained state of inspection readiness.
This leadership role, under the direction of the Senior Director, RDQ will provide support for junior staff members and mentorship within the RDQ PV function. The Associate Director, PV Quality plays a key role in promoting a quality culture that ensures sustained compliance to global, national and local regulations.
Heres What Youll DoParticipate in the development of quality and compliance strategies for the support of global pharmacovigilance activities.Work closely with the Moderna Global Pharmacovigilance and R&D Quality & Compliance (RDQ&C) Process Excellence and Training to support development of R&D policies and procedures related to PV activities.Partner closely with member of Global Pharmacovigilance and the QPPV to support the successful and compliant execution of Moderna PV activities.Conduct and report audits of Modernas Pharmacovigilance System, including but not limited to audits of PV processes, systems, vendors, and affiliates.Follow-up on CAPAs resulting from audit findings identified during PV audits to ensure effective remediation.Develop and maintain Annual Audit Plans for the RDQ&C GVP audit program.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.Actively participate as a key member of the inspection team for inspections of Modernas pharmacovigilance system, including RDQ Inspection Host and participate, as needed in PV Regulatory Authority inspections.Provide strategic input in the development of responses to Regulatory Authority inspection findings for inspections of Modernas PV system.Participate in Regulatory Authority inspection and provide input and review of responses to inspection observations and regulatory agency questions resulting from inspections .Contribute to the continuing development of a quality culture at Moderna.Travel, including international up to 35%.Additional duties as may be assigned from time to timeHeres What Youll Need (Minimum Qualifications)
BS/BA, MS or PhD / PharmD and a minimum of 10, 8, 6 years experience, respectively, in Biotech, Pharma or Clinical Research Organization.Audit certification (e.g., ASQ Lead Auditor) preferred.This role is based in our new LEED-certified HQ in Cambridge, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.Heres What Youll Bring to the Table (Preferred Qualifications)
Strong knowledge of relevant global guidelines and applicable GVP regulations, guidelines and local legislation.Knowledge of relevant FDA, EU, guidance for computerized systems is a plus.Experience working with CROs, vendors, and relationship management.Strong interpersonal skills and ability to interact effectively with all levels within the organization.Leadership skills to provide training, mentoring, and managing quality professionals.Experience leading / hosting regulatory authority inspections and developing responses to regulatory authority inspection findings.Ability to solve complex problems taking a broad perspective to identify innovative solutions.Ability to manage multiple projects in a fast-paced environment.Ability to collaborate and influence effectively in a dynamic, cross-functional matrix environment.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 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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