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Sr. Manager GCP Compliance

Company: Moderna Theraputics
Location: Cambridge
Posted on: June 7, 2021

Job Description:

The Role:

Reporting to the Sr. Director of GCP/GLP Auditing Research and Development Quality (RDQ) located at the Moderna Headquarters in Cambridge, MA, the Sr. Manager of GCP/GLP Auditing RDQ, will (i) be a key contributor in growing and shaping Moderna's GCP/GLP Auditing Function, (ii) aid in the establishment of Annual Audit Plans in support of Moderna's clinical studies, analytical studies, etc., ensuring compliance with Health Authorities Regulations (e.g., FDA, EMA, etc.), and (iii) contribute in the establishment of Moderna's Quality Management System for the areas of GCP, GLP and GVP. The appointee will also be responsible to partner with study teams to create a quality culture within Moderna and help reach a sustained state of inspection readiness.

Here's What You'll Do:

  • Participate in the development of GCP/GLP auditing strategies for the support of global clinical programs/trials, and non-clinical activities.

  • Contribute to the development of policies and procedures for the GCP/GLP/GPV RDQ functions, as well as provide guidance/review/approval of policies and procedures within these functional areas.

  • Partner closely with members of the Clinical and Research Development groups to support the successful and compliant execution of clinical and non-clinical studies.

  • Develop and/or provide input in the development of Annual Audit Plans (GCP/GLP), and study-specific audit plans.

  • Plan, execute and report audits, as necessary, and work with Moderna staff to ensure the proposed corrective actions received from the auditees are appropriate and that they are tracked to completion.

  • Help train/prepare Moderna employees for regulatory inspections (Sponsor inspections) and/or clinical and non-clinical sites/vendors.

  • Help host regulatory inspections, as necessary, and provide input and review of responses to regulatory agency questions resulting from these inspections.

  • Contribute in the continuing development of a quality culture at Moderna.

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

  • BS/BA, MS or PhD and a minimum of 8 years' experience, respectively, in Biotech, Pharma or Clinical Research Organization.

  • Working knowledge of relevant FDA, EU, ICH GCP guidelines, and GCP regulations.

  • Knowledge of relevant FDA, EU, ICH GLP and Pharmacovigilance guidelines and regulations an advantage.

  • Experience working with CROs, vendors, and relationship management preferred.

  • Excellent auditing skills and ability to communicate significant observations to Principal Investigators, Senior Scientists, etc., in a sound and factual manner.

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

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

Here's What We'll Bring to the Table:

  • On-site subsidized cafeteria or catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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.

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Keywords: Moderna Theraputics, Cambridge , Sr. Manager GCP Compliance, Other , Cambridge, Massachusetts

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