This job has expired

You will need to login before you can apply for a job.

Manager, Global Quality, Drug Product Development

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Sep 27, 2022
You need to sign in or create an account to save a job.

Job Details

The Role:

Reporting to the Senior Manager, Global Quality, Early Phase Product Development, the Manager, Global Quality Product Development will be responsible to provide Quality oversight of technical development and documentation management in line with internal and external requirements. The individual will collaborate with Technical Development teams to execute and maintain robust processes and systems supporting Modernas CMC development programs, from early clinical to commercialization.

Heres What Youll Do:

  • Provide Quality oversight to the execution of a phase appropriate Quality Management Systems to ensure GxP compliance for all aspects of Modernas Technical Development programs (from early phase clinical to support of commercialization)

  • Champion Quality by Design in process design and qualification

  • Contribute to deployment, execution, and maintenance of product development and design for quality systems, driving best practices, and ensuring data integrity

  • Oversee documentation, process and system supporting Technical Knowledge Management fit for progression from stage 1 to stage 2 of process validation

  • Partner with operational teams to deploy strategy, procedures and processes related to the Quality Management System for toxicology studies, IND enabling studies, clinical in-use studies from pilot to full scale operations

  • Verify Quality data, review and approve process and analytical development reports (such as equipment qualification, method validation, justification of specifications, stability, design of experiments, control strategy, process characterization, tech transfer, and comparability)

  • Support partners to escalate technical risks and issues as per quality escalation processes

  • Support regulatory filing as appropriate

  • Provide hands-on support in the day-to-day management of data collection systems and control within the GxP Quality Management System using digital solutions

  • Provide quality support to the functional lines for significant changes and issue management (Deviations/CAPAs), ensuring appropriate implementation of change and CAPA actions

  • Work collaboratively with team members to meet timelines and implement process improvements

Heres What Youll Bring to the Table:

  • Bachelor or MS degree, preferably in Sciences or Engineering

  • Experience in a biotech or pharmaceutical development environment (clinical and commercial combined) of 5-8 years

  • Working knowledge of applicable FDA, EU regulations and ICH standards/guidelines applied to development of process or analytics

  • Experience managing and executing tasks in electronic quality systems (Veeva) in a biopharma organization

  • Experience with process validation and Quality by Design (QbD) principles.

  • Experience of new product launch and regulatory filings is preferred

  • Strong hands-on experience with deviation/CAPA/change control management

  • Strong skills in Good Documentation Practices, and Data Integrity

  • Ability to interact effectively with operational organizations and leadership at all levels of the organization

  • Proven experience leading or contributing technical projects/teams, while meeting all deliverables and timelines using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way.

  • Outstanding communication skills (verbal and written)

  • Ability to navigate through ambiguity, rapid growth, and adaption to change.

  • Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.

  • A digital first, lean and curious mindset that allows you to constantly learn, challenge the status quo, and develop agile sustainable solutions.

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 persons 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.

#LI-LG1

-

Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company 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 and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

Facebook  Instagram  Twitter

 

Find Us
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert