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Specialist, Quality Control, Specifications & Change Controls

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

View more

Discipline
Clinical, Clinical Medicine, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

The Role:

Reporting to the Associate Director, Global QC Specifications & Change Controls, the Specialist, QC Specifications & Change Controls, will be collaborating closely with Modernas network of QC Laboratories, internal and external (affiliated Contract Testing Organizations (CTOs)/Contract Manufacturing Organization (CMOs)), with the main following responsibilities (not exhaustive):

  • Authoring Moderna Specification documents for Phase III and commercial products (in close partnership with TD function in terms of overall process and definition of specifications for products in development phases).

  • Lead/co-lead Specification relevant Change Controls, applicable locally and globally.

  • Supporting Commercial QC Operations in terms of Laboratory strategy and operational standards, continuous improvement initiatives and projects.

This position is expected to work in a highly collaborative and cross-functional team environment (including Technical Development groups) also supporting sites in regulatory and third party/HA inspections.

The individual will also act as liaison person to various groups including External QC US & OUS, Commercial & Clinical QC in US, Site Quality Assurance, Site MS&T, Regulatory and Technical Development.

Heres What Youll Be Doing:

Within the scope of Specification management process:

  • author & review Specification documents, global & local, for Phase III and commercialized products.

  • support definition of specifications & acceptance criteria for Phase III and commercial products.

  • support the definition and implementation of an end to end specification management process.

  • be active part of the Specification management process for products in development phases.

  • author and/or review specifications for products in development phases.

  • Actively collaborate with Veeva and LIMS System/Business Owner/s to implement the specification management process within the system.

  • support process improvement for Pharmacopoeia Compliance of Moderna testing methods, in partnership with Pharmacopoeia Compliance Lead and with local with AS&T experts.

  • edit/update local and/or global SOP or Policies about specification management process and/or for Laboratory relevant topics.

  • interact for continuous alignment with colleagues from Regulatory Departments.

  • oversee alignment between specifications in Moderna and at affiliated (CTOs)/(CMOs).

Within the scope of Specification Change Controls, globally relevant:

  • act as Change Owner/Coordinator for Specification Change Controls globally & locally relevant.

  • execute implementation actions (Action Owner/SME) of all (local, regional) specification related Change Controls.

  • align always within the extended QC community (including Moderna AD, ATO & QC Labs, Moderna International QC organization and QC Labs from affiliated CMOs/CTOs).

Within the general scope of the role, within Global QC function:

  • be an active member of Moderna extended QC community, interacting with Commercial and Clinical QC in Norwood, with Moderna International QC organization and, if required, with CMO/CTO QC Labs.

  • provide technical support, in the context of QC testing, for sites and product related inspections (e.g. Pre-Licensing Inspection (PLI) and periodic cGMP inspections).

  • collaborate for proactive identification of risk and compliance issues, manage prioritization of transformational and continuous improvement activities to deliver efficient laboratory solutions.

Heres What Youll Bring to the Table:

  • Bachelors degree with a minimum of 5-7 years of experience in the pharmaceutical industries, with 3+ years experience in Quality Control Labs in a cGMP organization. Advanced degree preferred, fluent in written and spoken English.

  • Deep understanding and experience with US, EU and ICH guidelines and regulations.

  • Good knowledge and expertise in analytical method lifecycle and transfer management.

  • Good experience in managing product specifications globally & locally relevant, both in commercial and development phases.

  • Good experience in coordination of Change Controls affecting QC operations.

  • Good experience with authoring and review of Quality memo, procedures, policies, risk assessments.

  • General experience in data analysis and statistical evaluation and trending of data.

  • Ability to think critically and demonstrate troubleshooting and problem-solving skills.

  • Experience participating in inspections as a Stability/QC testing (SME) and in direct interactions with world-wide/diverse Health Authorities (e.g. FDA, MHRA, EMA, PMDA, ANVISA).

  • Ability to interact effectively with all levels of personnel within the organization and externally with CTOs and CMOs. Ability to navigate through ambiguity and rapid growth and adapt to change.

  • Experience in assessing, writing, and evaluating OOSs and laboratory investigations.

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.

#LI-PL1

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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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