Director, QMS Delivery Lead, Digital Quality

The Role

Moderna is looking for a Director, QMS Delivery Lead, Digital Quality to join our Digital Team and to provide oversight for the implementation, development and maintenance of quality programs, systems and supportive processes and procedures. This critical role will ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.

Heres What Youll Do

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

• Partner with the Quality business to understand and evaluate new stakeholder needs

• Define Modernas quality applications portfolio landscape

• Overall responsibility of business engagement, project plan, scope definition, timelines, and budget

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

• Ensure deployed solutions are in alignment with business needs, in compliance 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 drive a risk-based approach methodology 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

• Additional duties as may be assigned from time to time

Heres What Youll Need (Minimum Qualifications)

• Experience with implementing EQM systems such as Veeva, DMS, Trackwise etc.

• Minimum of a Bachelors in computer science, Life Science, or equivalent industry experience, and 10+ years of relevant technical experience including but not limited to:

  • 10+ years implementing Quality Assurance computer systems

  • 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)

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

• 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)

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

• Lead with a focus on delivery

• Experience with large digital implementation solutions in the quality area, advantage to Veeva QMs implementation

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!

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.

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