Associate Director, Inspection Management, R&D Quality at Moderna Therapeutics in Cambridge, Massachusetts

Job Description:

The Role:
Reporting to the Sr. Director of Quality Strategies within Research & Development Quality (RDQ), located at the Moderna Headquarters in Cambridge, MA, the Associate Director of Inspection Management, will be a key contributor in growing and shaping Moderna's newly-established R&D Quality function focusing on contributing to building a highly functioning inspection team of R&D quality professionals, aid in the establishment of planning and supporting regulatory authority inspections, ensuring compliance with regulations (e.g., FDA, EMA, etc.) and will be responsible for management of the overall Regulatory Inspection program supporting GLP, GCP, GVP and CSV across R&D. The appointee will partner with R&D to create a quality culture within Moderna and help reach a sustained state of inspection readiness.

Here's What You'll Do:

• Participate in the development of quality and compliance strategies for the support of global Health Authority inspection activities.




• Work closely with Moderna R&D and RDQ QMS to support development of R&D policies and procedures related to inspection activities.




• Partner closely with members of R&D to support the successful and compliant execution of Moderna regulatory inspection activities.




• Develop and maintain Inspection Management plans and strategies for the R&D Quality inspection management program.




• Review and provide input into study team inspection readiness activities, storyboards, etc.




• Ensure any critical and major inspection findings have appropriate Corrective and Preventative Actions (CAPA) and are tracked to completion and verification of effectiveness.




• 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 Moderna's R&D programs.




• Provide expert guidance and direction in the development of responses to Regulatory Authority inspection findings for inspections of Moderna's R&D programs.




• Participate in regulatory authority inspections, including planning, logistics, training and execution, and provide input and review of responses to inspection observations and regulatory agency questions resulting from these inspections.




• Contribute in the continuing development of a quality culture at Moderna.

Here's What You'll Bring to the Table:

• BS/BA, MS or PhD and a minimum of 12, 10, 9 years' experience, respectively, in Biotech, Pharma or Clinical Research Organization.




• Strong 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 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 coordinating, training and logistical planning for 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.

Here's What We'll Bring to the Table:

• On-site subsidized cafeteria or catered lunches


• Company-provided iPhone


• Free parking, monthly subway pass or a subsidized commuter rail pass


• Free annual corporate membership to Bluebikes


• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP


• Flexible Spending Accounts for medical expenses and dependent care expenses


• 16 weeks of 100% paid parental leave for all new parents


• 16 weeks 100% paid family caregiver leave


• 20 weeks 100% paid medical leave


• Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)


• Adoption assistance and discounts to local childcare centers, as well as access to care.com


• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately


• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability


• Voluntary legal assistance plan


• 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

-