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Director, Product Quality Lead

Employer
Moderna, Inc.
Location
Norwood, MA
Start date
Feb 2, 2023

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Job Details

The Role:

Reporting to the Sr Director, Global Quality Operations, the Director, Product Quality Lead will be responsible for providing quality oversight of drug products throughout the product and design control lifecycle. Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality and design control risks. Ensures quality management of products and processes lifecycle, leading improvement, and alignment with current regulatory expectations.

The individual will ensure robust processes are implemented across Modernas global operations for management of clinical and commercial product and process lifecycle quality (control strategy, technical transfer and changes, process validation lifecycle, quality monitoring). The individual will partner cross-functionally with Technical Development, Supply Chain, Manufacturing Sciences & Technology, Manufacturing, Digital, and Regulatory as the Quality representative on relevant CMC Governance Boards to enable efficient communication and strategic decision-making related to the quality and design control of drug and combination products in support of Modernas CMC programs. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.

Heres What Youll Do:

  • Provide quality oversight and strategic guidance throughout the CMC lifecycle management of Modernas vaccines and therapeutics inclusive of combination product design controls

  • Interface in a matrix environment with drug and combination product design and development teams to develop and deploy policies/SOPs/standard reports/KPIs for management of continued process verification, Technical transfer and Control Strategy

  • Coordinate deployment and application of controls supporting risk-based continued process verification and monitoring of lifecycle product quality.

  • Ensure significant Quality risks are escalated and mitigated in a timely manner

  • Act as global Quality representative in cross-functional forums to provide support and oversight to internal and external manufacturing and testing facilities for application of Global Quality Management System, policies, SOPs and Standards throughout clinical and commercial lifecycle of products.

  • Provide quality support for significant changes and issue management (Deviations/CAPAs) across Modernas internal and external manufacturing and testing sites

  • Contribute to improvement and harmonization initiatives across Global Quality Operations in line with current Regulatory expectations.

  • In collaboration with quality system business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement of new and emerging technologies to ensure quality and compliance frameworks are established

  • In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve efficiencies of processes

Heres What Youll Bring to the Table:

  • Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 15-20 years; 10-15 with MS.

  • Working knowledge of relevant FDA, EU regulations and ICH standards/guidelines and experience in supporting successful regulatory inspections.

  • Knowledge in design controls, risk management, and quality system requirements.

  • Working knowledge of control charts and statistics applied to process validation and data trending using statistical programs and software (e.g, JMP, Looker, Statistica, Spotfire)

  • Experience in management or application of quality systems and e-systems in a biopharma organization.

  • Experience in computerized systems, automation, manufacturing,and testingwithin biotechnology industryis a plus.

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

  • Proven ability to lead and manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines.

  • Excellent interpersonal skills 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 and rapid growth and adapt to change.

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

  • A digital first and curious mindset that allows you to constantly learn and challenge the status quo.

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.

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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

 

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

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