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Senior Director of Quality Assurance - GCP

Formation Bio

Formation Bio

Sales & Business Development, Quality Assurance
New York, NY, USA · Remote
Posted on Thursday, December 21, 2023

About Formation Bio

At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.

At Formation Bio we license clinical stage drug assets and develop them in-house using our proprietary, technology-driven platform. Over the past few years, we have been able to significantly expedite the drug development process, evidenced by our acceleration of over 300 clinical trials and reducing trial durations by up to 50%. This innovation translates to getting life-saving drugs to market 1-3 years faster, where we specialize in partnering with and nurturing in-house clinical-stage drugs. Our diverse team of experts come from across multiple industries, combining the best of tech and pharma talent.

Join our culture of innovation where your work directly contributes to transforming patient care in areas such as rheumatology, dermatology, CNS, and cardiometabolic diseases. Our dynamic environment blends advanced technology with strategic drug development, speeding up the delivery of new treatments. Here, every role plays a part in our mission to bring new treatments to patients faster and more efficiently.

About the role

The Director, GCP Quality Assurance (QA) will support the organization by providing quality management oversight for Formation Bio clinical trial activities. You will create and execute GCP quality management strategy for all ongoing Formation Bio trials and development projects. This includes developing and executing quality plans, conducting quality reviews, developing a risk-based audit program and plans for GCP activities , coordinating and participating in GCP audits, as well as hosting audits from external parties, including inspectional activities as appropriate. This role will also support due diligence activities for licensing opportunities. An integral member of the project team, you will foster cross-functional partnerships, lead risk management activities (risk identification, evaluation, control/mitigation, reporting) and provide pragmatic and sensible interpretation of the applicable regulations. You will closely collaborate with other members of the QA team and coordinate activities to ensure GXP compliance of Formation Bio activities.

Responsibilities

  • Development and implementation of GCP quality management at Formation Bio
  • Lead the GCP QA Strategy implementation
  • Represent GCP QA at project team meetings
  • Establish an inspection readiness program
  • Conduct and oversee GCP audits and inspection activities as needed
  • Evaluate status of GCP compliance for management reporting
  • Provide sensible interpretation of GCP regulations

About You

  • Minimum of 15-20 years of increasing responsibility in clinical development, clinical trial quality or GCP QA.
  • In-depth knowledge of the application of GCP regulations, ICH Guidelines, FDA Regulations and Guidance
  • Experience in implementing quality management programs for clinical development activities

We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at Formation Bio. The target salary range for this role is $190,000 - $235,000.

On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits – learn more about them and our compensation philosophy here.

If this range doesn’t match your expectations, please still apply because we may have something else for you.


You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.