Associate Director, Global Quality, Regulatory Surveillance

The Role:

Reporting to the Sr. Director of Global Quality Systems, the Associate Director, Global Quality, Regulatory Surveillance will be responsible for setting, communicating and overseeing creation and management of a Quality led- Global Quality Regulatory Intelligence function.  This role will have the remit and opportunity to create a program and process supporting timely flow of key regulatory and compliance information, working collaboratively across all sites and relevant stakeholder functions to ensure regulatory requirements expectations are known, communicated, and implemented across Businesses. Sr. Manager/Associate Director, Global Quality, Regulatory Intelligence is a key quality systems management role.

Here’s What You’ll Do

• This newly created key position will develop and implement integrated and sustainable Regulatory Intelligence Quality strategies, and activities for Moderna’s clinical and commercial products supporting a robust compliant lifecycle for the programs.

• This role is highly visible within the Global Quality team, working to help define this new function and identifying solutions and processes, and aligning with key partners on implementation of new requirements

• Establish sources of intel to thoroughly scan Moderna’s Global regulatory environment; determine which new or revised requirements should be assessed by Moderna for impact to our products and processes

• Lead the assessment of these new or changed requirements in collaboration with cross-functional representatives, and ensure that this assessment, as well as plans to bring processes and products into compliance, are well documented

• This leader will provide guidance to the business teams on Regulatory requirements and lead and assist where needed, during implementation and will demonstrate proven experience interpreting Regulatory compliance trends which may improve Moderna’s business operations globally with the ability to create action plans and implement solutions.  This person will build collaborative process with Global Quality and related Global Manufacturing Supply functions and other Moderna functions as well as partners to ensure implementation of Regulatory Intelligence strategies including integrated processes for all Operational Units and Regions, R&D processes, and Quality Governance Forums

• Conduct regular review and assessment of incoming  Regulatory Intelligence and communicate any concerns, trends, gaps, alerts  to Quality management in a timely fashion

• Ensure that QMS documents are updated as needed to reflect new requirements

• Will have a bias to think and act globally to anticipate potential problems and risks related to regulatory compliance expectations

• You will oversee design and sustainability of overall Regulatory Intelligence processes for Moderna.

Here’s What You’ll Bring To the Table

• Bachelor’s Degree with minimum of 10-15 years in biopharma experience, 3-5 years in Regulatory Intelligence

• Experience with Reg Intel system such as Redica.

• Comprehensive knowledge of GXP regulations for document and records management

• Ability to interact effectively with all levels of personnel within the organization.

• Reputation for superior customer service with excellent interpersonal skills

• Strong cross-functional and matrix team leadership

• Biased to reduce complexity and create simple and organized data systems

• Proficiency in creating high quality procedures that are easy to read and understood

• Desire and interest to leverage new technology and innovative information management tools

• Outstanding communication skills (verbal and written). 

• Demonstrated problem detection and problem resolution skills

• Ability to take initiative and work independently with minimal oversight

• Must possess demonstrated organizational skills

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 winter shut down 
  •    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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

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 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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