Senior Manager/Associate Director, GCP/GLP/GVP Compliance

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
October 04 2019
Ref
R1808
Discipline
Life Sciences, Biology
Organization Type
Biotech
The Role:

Reporting to the Sr. Director of GCP/GLP/GVP Quality Assurance, located at the Moderna Headquarters in Cambridge, MA, the Sr. Manager / Associate Director of GCP/GLP/GVP Quality Assurance, will (i) be a key contributor in growing and shaping Moderna's newly-established GCP/GLP/GVP Function, (ii) be responsible for helping to establish Moderna's Quality Management System for the areas of GCP, GLP and GVP, (iii) 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.). 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/GPV QA strategies for the support of global clinical trials, and non-clinical activities.
  • Establish and maintain policies and procedures for the GCP/GLP/GPV QA function, 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 GPV), 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.
  • 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.
  • 10-20% Travel Required


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 Biotech, Pharma or Clinical Research Organization.
  • Working knowledge of relevant FDA, EU, ICH GCP guidelines, and GCP and/or GLP regulations.
  • Knowledge of relevant FDA, EU, ICH 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:
  • Daily on-site 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
  • 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)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-AG1

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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