Manager, Quality Systems
Location: Somerville, Massachusetts, 02143, United States
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs.
With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for recurrent C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn’s disease, respectively.
The Manager, Quality Systems is responsible for supporting the building and delivering a Quality Management System (QMS) that enables productivity, continuous improvement, and adherence to applicable regulations. Builds impactful relationships and collaborations across the organization while relying on practical experience to advance GxP quality systems strategy in a fast-paced organization.
- Provide leadership for Quality systems function through development and implementation of the overall quality systems strategic plan.
- Promote a culture of quality, compliance and accountability mindset, including continuous improvement through the establishment of KPI metrics
- Support regulatory inspections and third-party audits, and conduct inspection readiness activities
- Manage/Support the internal, external and supplier audit program
- Establish/maintain a robust program for complaints, product recalls and product retrievals
- Provide support and oversight 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
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
- Review and approve QMS documentation including controlled documents, training material, deviations, laboratory investigations, CAPAs and change controls
- Support the preparation of and conduct Quality Management Reviews
- Establish and execute a risk management 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
- Bachelor’s degree in the Life Sciences or in a related field
- At least 6 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 strategies and tools
- Late clinical stage and commercial cGMP quality systems and compliance experience preferred
- Proven management and/or leadership experience.
- 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 Harvard Pilgrim 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 or grow your 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 (temporarily closed due to COVID), fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap. 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.
*Only facility-dependent employees are working on-site in Somerville until further notice.
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.