Skip to main content

This job has expired

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

Director, QMS Product Lead

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Jan 24, 2024

View more

Job Details

The Role

Moderna is looking for a Product Leader on our Digital Quality team to lead the QMs space. In this role, you will provide strategic leadership and oversight for the implementation, development and maintenance of quality programs, systems and supportive processes and procedures. This role is critical to ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

This role is based in Norwood, MA.

Heres What Youll Do

  • Provide leadership, direction, and vision for the development of the future Moderna Quality application landscape with focus on QMs, ALM, etc.

  • Successfully partner with Quality business to understand and evaluate new stakeholders needs

  • Define and gain alignment of Modernas quality applications portfolio landscape

  • Be a delivery focused leader, with overall responsibility of business engagement, project plans, defining scope, timelines and budget

  • Experience with large digital implementation solution at the quality area, advantage to Veeva QMs implementation

  • Lead a large team of technical delivery teams across multiple projects of various complexities

  • Ensure deployed solutions are in alignment with business needs, in compliant with Data Integrity requirements

  • Deliver critical Global Quality projects on-time and within budgetary requirements

  • Provide guidance to team members on software development life cycle, computer validation, and driving risk-based approach methodologies with all stakeholders.

  • Provide oversight to the implementation and validation of software applications/modules and associated interfaces according to business needs and internal procedures (support system upgrades, change control, retrospective validation, software add-on installations where capable).

  • Work with project teams and business/quality representatives to ensure compliance with regulatory requirements such as FDA, CAPAs, GxP

Heres What Youll Need

  • Minimum of a Bachelors in computer science, information systems management, computer engineering, Life Science, or equivalent industry experience, and 15+ years of relevant technical experience including but not limited to:

  • 12+ years implementing Quality Assurance computer systems, Veeva specifically (QMs, DQMs)

  • 7+ years working in regulated Biotech or pharmaceutical companies

  • Vast experience in regulated environment (GxP)

  • Experience in 21 CFR Part 11, GAMP

  • Experience in CDLC (Agile or Waterfall)

  • Experience working in a highly regulated environment within the pharmaceutical Industry

  • Knowledge and experience of cGMP and its implementation to QA systems and quality assurance process

Heres What Youll Bring to the Table (Preferred Qualifications)

  • Strong compliance and quality mind, with ability to mirror technical knowledge, and science

  • Experience working in a matrixed environment

  • Ability to effectively communicate with all levels within the organization

  • Ability to lead and motivate teams to reach a common goal

  • Ability to adapt to a fast changing, startup like environment

  • Strong influencing, facilitating and consulting skills in working with stakeholders across all levels of the organization

  • Experience in defining, scoping and managing technology initiatives

  • 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 extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

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

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

-

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

 

Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

Get job alerts

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

Create alert