Associate Director, Quality Services

The Role

In this role, you will provide oversight, strategic direction, management support and guidance for building and maintaining Moderna’s R&D Quality Management System (QMS), focusing on GCP/GLP, GCLP/GVP/CSV activities conducted by Moderna and its service providers.  You will be responsible for establishing strategies to drive optimal performance of the R&D QMS through management of key projects and programs impacting the QMS, ensuring consistent implementation of deliverables across the R&D organization and proactive identification and mitigation of potential risks impacting the QMS .  Additionally, you will support the appropriate integration a oversight of the R&D QMS within the Moderna Global QMS. The appointee will also be responsible to champion a quality culture within the R&D organization and drive toward a sustained state of inspection readiness.

Here’s What You’ll Do

• Partner closely with R&D colleagues to develop and maintain program/project plans and deliverables, ensuring appropriate communication of status to key stakeholders and R&D Leadership.

• Collaborate with R&D colleagues to assess/support the state of the R&D QMS by evaluating the major elements for both current state and as part of the ongoing assessment of the QMS for continuous improvement.

• Support oversight of all R&D quality documents to ensure compliance to applicable regulations and internal requirements.

• Lead and contribute to strategic and operational improvement initiatives impacting the QMS.

• Provide active R&D representation/participation in the Global QMS organization to ensure appropriate R&D GxP integration.

• Actively participate as a Subject Matter Expert for health authority inspections of Moderna as it relates to the R&D QMS (e.g., procedural documents, training, issue management, risk management).

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

• Additional duties as may be assigned from time to time.

Here’s What You’ll Need (Minimum Qualifications)

• BS/BA, MS or PhD and a minimum of 12-15, 8-10, 10 years’ experience, respectively, in Biotech, Pharma or Clinical Research Organization.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Knowledge of metrics and data analytics best practices as they relate to a QMS.

• Strong knowledge of project/program management tools and methodology.

• Expert level knowledge of Excel, PowerPoint and other office applications.

• Strong knowledge of relevant FDA, EU, ICH GCP guidelines.

• Knowledge of relevant FDA, EU, ICH guidance for GVP, CSV and GLP.

• Experience working with CROs, vendors, and relationship management.

• Strong interpersonal skills and ability to interact effectively with all levels within the organization.

• 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.

• 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 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 ext