Sr. Director, Quality Services at Moderna Therapeutics in Cambridge, Massachusetts

Job Description:

The Role:
Reporting to the Vice President of Research & Development Quality (RDQ), located at the Moderna Headquarters in Cambridge, MA, the Senior Director of R&D Quality, 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 team of R&D quality professionals. This leadership role will provide oversight, strategic direction, management support and guidance for building and maintaining a function within the RDQ organization that is responsible for (i) Issue and Inspection Management (ii) the R&D Quality Management System (QMS), (iii) Clinical & Non-Clinical Compliance, and (iv) a Computer Systems Validation audit program. Additionally, the Senior Director, Quality Services will aid in the establishment of Annual Audit Plans in support of Moderna s clinical studies, analytical studies, etc., ensuring compliance with Health Authorities Regulations (e.g., FDA, EMA, etc.). The appointee will also be responsible to partner with study teams to create a quality culture within Moderna and drive toward a sustained state of inspection readiness.

Here s What You ll Do:
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Participate in the development of quality and compliance strategies for the support of global clinical trials, and non-clinical activities.
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Oversee a program for establishing, administering and maintaining R&D policies and procedures and provide guidance to ensure appropriate review and approval of policies and procedures within the R&D functional areas.
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Partner closely with members of the Clinical and Research Development groups to support the successful and compliant execution of clinical trials and non-clinical studies.
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Develop and/or provide input in the development of Annual Audit Plans (GCP/GLP and GPV).
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Provide oversight to an issue management program that ensures early detection of issues, development of appropriate and robust corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness.
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Oversee the Inspection Management program for R&D that provides a framework for management of Clinical Investigator Site inspections, Sponsor inspections and other relevant inspection activities by Regulatory Authorities.
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Participate in regulatory authority inspections, including serving as Inspection Host, as necessary, and provide input and review of responses to inspection observations and regulatory agency questions resulting from these inspections.
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Establish, maintain and oversee a computer system validation audit program.
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Ensure and oversee development of applicable quality services ? (e.g., R&D Quality Newsletter, Regulatory Intelligence, etc).
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Contribute in the continuing development of a quality culture at Moderna.

Here s What You ll Bring to the Table:
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BS/BA, with at least 20 years experience in Biotech, Pharma or Clinical Research Organization.
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Strong knowledge of relevant FDA, EU, ICH GCP guidelines, and GCP and GLP regulations.
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Knowledge of relevant FDA, EU, guidance for computerized systems.
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Experience working with CROs, vendors, and relationship management.
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Strong interpersonal skills and ability to interact effectively with all levels within the organization.
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Proven record training, mentoring, and managing a staff of quality professionals.
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Experience leading / hosting regulatory authority inspections and developing responses to regulatory authority inspection findings.
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Ability to solve complex problems taking a broad perspective to identify innovative solutions.
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Experience managing and developing quality systems for development activities.
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Ability to manage multiple projects in a fast-paced environment.
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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:
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The Company s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been ranked in the top ten of Science s list of top biopharma industry employers for the past five years. To learn more, visit .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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.
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