Back

Associate Director, Nonclinical (GLP/GcLP) Research and Development Quality

Moderna

Location Pin Icon
Cambridge, MA
LOCATION

Job Description

As posted by the hiring company

Job Overview:

The Role:
Reporting to the Senior Director, Quality Strategies RDQ, located at the Moderna Headquarters in Cambridge/Norwood, MA, the Associate Director of Nonclinical (Good Laboratory Practice/Good Clinical Laboratory Practice (GLP/GcLP), will be a key contributor in growing and shaping Moderna’s global R&D Nonclinical (GLP/GcLP) Quality Program and team. The Associate Director will proactively partner with R&D operational functions, aid in the establishment and execution of Quality Strategies and Plans in support of Moderna’s R&D Nonclinical activities and provide oversight of the R&D Nonclinical Quality audit program (Process, Study, Vendor Audits). The Associate Director should have expert knowledge in global Health Authority Regulations including US FDA 21 CFR Part 58, any applicable GLP/GcLP international regulations, and GLP/GcLP guidance and is responsible for the oversight of Moderna Biomarker laboratory activities and associated bioanalytical analysis. The Associate Director will also partner with R&D to create a quality culture within Moderna, provide business support, process improvements and inspection support as needed. This position may interact with regulatory agencies and corporate partners during inspections and audits, and it may require minimal travel for auditing vendors.

Here’s What You’ll Do:

  • Lead, participate and actively engage in strategic initiatives which require GLP/GcLP support.

  • Proactively partner with R&D operational functions providing expert quality support and guidance.

  • Promote and monitor the quality and performance of operations as they relate to nonclinical and bioanalytical studies.

  • Provide strategic direction for the Nonclinical Audit Program for Moderna’s Biomarker laboratory activities.

  • Plans, conducts and reports internal, in-process, study, and process audits.

  • Manages audit CAPAs and responses as per Moderna procedures.

  • Support regulatory agency inspections and vendor audits as needed.

  • Initiates frequent communication with Senior Management to discuss timelines, critical regulatory issues, industry best practices and emerging trends.

  • Contribute to the R&D Quality Regulatory Intelligence program

  • Contribute to the R&D Quality Newsletter

  • Participate in compliance projects and initiatives.

  • Serve as a manager, trainer and mentor to the R&D Quality Nonclinical team.

  • Contribute to the continued development of a quality culture at Moderna.

  • Perform other tasks as assigned by line manager.

Here’s What You’ll Bring to the Table:

  • BS/BA, MS or PhD and a minimum of 12, 10, 9 years’ experience, respectively, in pharmaceutical / biotech industry with experience in the GLP/GcLP environment.

  • 10+ years experience in a GLP/GcLP QA function in an international environment.

  • Expert understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for GLP/GcLP (understanding of regulatory guidelines for other countries a plus).

  • Expert knowledge of GLP/GcLP related audits activities and business standards.

  • Bioanalytical technology, including but not limited to LIMS, PCR, plate reader, and mass spectroscopy proficiency is highly desired.

  • Expertise with business office applications, word processing and spreadsheets.

  • Demonstrated knowledge and/or prior experience in Quality Assurance.

  • Outstanding communication skills (verbal and written)

  • Ability to manage multiple projects in a fast-paced environment.

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

  • Ability to make decisions that are guided by policies, procedures, and business plan; receives guidance and oversight from manager.

  • Relies on experience and judgment to plan and accomplish goals.

  • Excellent organizational skills and keen attention to detail.

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 person’s 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

-