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Form of workThe Role:
Reporting to the Senior Director of Pharmacovigilance Quality, Research & Development Quality (RDQ), located at the Moderna Headquarters in Cambridge, MA, the Senior Manager of Pharmacovigilance Quality Assurance (PVQA), will be a key contributor in growing and shaping Modernas newly established R&D Quality function focusing on contributing to building a highly functioning team of R&D quality professionals.
This role will support the ongoing development and operational activities of the Local affiliate functions responsible for Moderna Clinical Safety and Pharmacovigilance (CSPV) organization, Global Regulatory Science (GRS) and Global Medical Affairs (GMA). This includes alignment of local initiatives, goals, and activities with R&D QA goals.
Ensure local implementation of global standards and procedures.
Supports regulatory inspections and partner audits of Local affiliate within assigned region (e.g., MHRA, EMA inspections).
Heres What Youll Do:
Work closely with the Moderna Clinical Safety and Pharmacovigilance (CSPV) and other related functions and R&D Quality QMS to support development of R&D policies and procedures related to PV activities.
Partner closely with members of CSPV and other cross-functional departments to support the successful and compliant execution of Moderna PV system activities.
Some involvement in the organization of appropriate support for the preparation, conduct and follow-up of PV System Audits, until closure.
Ensure completion of audit/inspections PV related Corrective and Preventive Actions (CAPAs) to ensure timely completion and effectiveness to prevent recurrence.
Leads coordination of investigations, CAPA plans, and cross-functional discussions and root cause analyses. Ensures that investigations are thorough and that CAPA are appropriate for elimination of root cause and prevention of reoccurrence.
Assesses and identifies risk and evaluates deficiencies while partnering with business owners to develop remediation plans.
Provides thorough assessment of CAPA activities and documentation to ensure consistency and accuracy and compliance with company standards and procedures.
Monitors and reports metrics for the CAPA system including on-time closures.
Verifies effectiveness of CAPAs.
Assist in the development of Annual Audit Plans for the R&D Quality GVP audit program.
Review and provide input into the quality sections of the PSMF.
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.
Contribute to the continuing development of a quality culture at Moderna.
Manage interfaces with QA departments of service providers, to ensure QA oversight of service providers and that any risk to Moderna business is mitigated.
Approximately 50% of time is spent in the audit role.
Heres What Youll Bring to the Table:
BS/BA, MS or PhD and a minimum of 5- 10 years experience, respectively, in Biotech, Pharma or Clinical Research Organization.
Strong knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable GVP regulations, guidelines, and local legislation.
Must have at least 5 years GVP experience.
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.
Proven record training, mentoring, and managing a staff of 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 effectively in a dynamic, cross-functional matrix environment.
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 options
- Flexible Spending Accounts for medical expenses and dependent care expenses
- Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
- Family care benefits, including subsidized back-up care options and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive preferred pricing on Peloton fitness equipment
- Adoption and family-planning benefits
- Dedicated care coordination support for our LGBTQ+ community
- Generous 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 thereafter - Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 401k match and Financial Planning tools
- Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
- Complimentary concierge service including home services research, travel booking, and entertainment requests
- Free parking or subsidized commuter passes
- Location-specific perks and extras!
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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