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Director, Quality and Compliance

Company: Finch Therapeutics Group, Inc.
Location: Somerville
Posted on: February 14, 2021

Job Description:

Location: Somerville, Massachusetts, 02143, United States Full-time Director, Quality and Compliance About Finch Finch is a clinical-stage company developing novel microbiome drugs to serve patients with serious unmet medical needs. Our machine learning-based platform mines molecular data collected from human interventional studies to identify the microbial communities driving positive patient outcomes in different disease areas. By developing drugs from microbial communities that have already demonstrated therapeutic effects in humans, we are pioneering a new approach to drug discovery and rapidly transforming the promise of the microbiome into a reality for patients. Our lead therapeutic candidate, CP101, is initially targeting the prevention of recurrent C. difficile infection (CDI). CP101 met its primary endpoint in a large placebo-controlled trial in recurrent CDI, providing the first positive pivotal data for an oral microbiome drug. We also have programs targeting the treatment of chronic hepatitis B, children with autism and serious GI symptoms, as well as two programs partnered with Takeda Pharmaceuticals targeting inflammatory bowel disease. Position Summary The Quality & Compliance Director is responsible for building and delivering a Quality Management System (QMS) that enables productivity, continuous improvement, and adherence to applicable regulations. Build impactful relationships and collaborations across the organization while relying on practical experience to advance GxP quality systems and compliance strategy in a fast-paced organization.-- Responsibilities / Duties

  • Provide leadership for Quality & Compliance (Q&C) function through development and implementation of the overall quality systems and compliance strategic plan. The Q&C function includes Quality Systems, Compliance, Document Control and Training
  • Develop and provide mentorship to direct reports
  • Plan, develop and manage Q&C departmental budget
  • Promote a culture of quality, compliance and accountability mindset, including continuous improvement through the establishment of KPI metrics
  • Host regulatory inspections and third-party audits, and conduct inspection readiness activities
  • Manage the internal, external and supplier audit program
  • Establish and maintain a robust program for complaints, product recalls and product retrievals
  • Provide management of the quality management systems, e.g., change controls, deviations, investigations, CAPA
  • Monitor the overall quality system effectiveness, continuous improvements, trending, lessons learned, and striving for operational excellence
  • Lead the preparation of and conduct Quality Management Reviews
  • Establish a risk assessment program
  • Monitor and continuously improve the efficiency, effectiveness and compliance of processes and procedures
  • Represent Quality at designated cross-functional project/program team meetings
  • Other duties as may be required
  • May require up to 10% travel Qualifications
    • Bachelor's degree in the Life Sciences or in a related field
    • At least 10 years of experience in pharmaceuticals, biotech or related industries
    • Strong knowledge of regulatory compliance practices, FDA regulations 21CFR 210, 211, 11, 600, 1271, as well as applicable ICH and WHO Guidelines and international GxP standards.
    • Extensive knowledge of investigation techniques, risk assessment strategies and tools
    • Late clinical stage and commercial cGMP quality systems and compliance experience
    • Proven leadership experience and people management skills
    • Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution
    • Ability and desire to work in a fast-paced and dynamic environment that will require management of several competing priorities while driving projects forward and meeting program/project deliverables
    • Strong collaboration, team building, and written and oral communication skills
    • Independently motivated and detail-oriented with stellar problem-solving ability More About Finch Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we'll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.
      • Our formal benefits include medical, dental, and vision coverage through Blue Cross Blue Shield in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start a family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
      • We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA include an in-office gym with a shower and towel service, fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap, and highly subsidized meals through LeanBox.. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team. *Though only facility-dependent employees are currently working onsite in Somerville, Ma, we all plan to return to the office when it's safe to do so. Equal Opportunity Employer We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.

Keywords: Finch Therapeutics Group, Inc., Somerville , Director, Quality and Compliance, Executive , Somerville, Massachusetts

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