Sr./Director, GCP/GLP/GVP Compliance

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
March 07 2019
Ref
R1038
Discipline
Life Sciences, Biology
Organization Type
Biotech
Sr./Director, GCP/GLP/GVP Compliance

The Role:

Moderna Therapeutics is seeking a Director/Senior Director of GCP/GLP/GVP Compliance to support clinical development programs at its Cambridge headquarters. This is a newly created role intended for a forward-looking Quality professional who is excited to join a strategic team responsible for executing GCP/GLP/GVP compliance and audit activities for messenger RNA therapeutics as an unprecedented new drug modality. This new leadership role reports to our Head of Quality.

Here's What You'll Do:
  • Plan and lead all GCP, GLP and GVP audit activities (international and domestic), including clinical investigator sites, contract clinical laboratories, contract bioanalytical laboratories, and CROs to evaluate and monitor compliance status
  • Identify and assess GCP, GLP and GVP compliance risk areas and develop and implement risk mitigation measures
  • Assess GLP, GCP and GVP deviations and ensure the development and implementation of appropriate CAPA's
  • Develop and implement standards, policies and procedures for GCP/GLP/GVP regulatory compliance
  • Develop and measure quality metrics to drive consistent quality standards relating to GCP, GLP and GVP activities
  • Ensure compliance with company's procedures and regulatory requirements
  • Review and provide input into non-clinical and bioanalytical documentation (e.g. protocols, method validations, study reports)
  • Provide guidance, interpretation and information on GCP, GLP and GVP regulations, standards and quality systems
  • Facilitate GCP/GLP/GVP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies
  • Present quality data and metrics at Quality Council management review meetings
  • Advise senior management of critical quality and compliance related issues and develop corrective actions to mitigate quality and compliance risks


Here's What You'll Bring to the Table:
  • BA/BS Degree in a scientific/engineering discipline
  • Minimum 15+ years' experience in Biotech or Pharma
  • 8+ years of experience in Quality Systems related to GCP, GLP and GVP.
  • Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement
  • Extensive experience auditing CROs, clinical sites and contract clinical and bioanalytical laborartories
  • Understanding of domestic and international GLP/GCP/GVP requirements
  • Outstanding communication skills (interpersonal, verbal and written)
  • Proven track record of industry success
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
  • Possess strong written and verbal communication skills
  • Working knowledge of FDA and global regulatory guidance as they relate to bioanalytical method validation preferred
  • Ensure quality agreements are established, as necessary, with Moderna's key GCP/GLP/GVP vendors
  • Ability to thrive in a fast- paced, innovative environment while remaining flexible, proactive, resourceful and efficient
  • Ability to develop relationship with key stakeholders, good conflict management and negotiation skills
  • Ability to analyze complex issues in order to develop relevant and realistic plans, programs and recommendations


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
  • 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


Why join Moderna Therapeutics

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-AE1

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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