Senior Manager, Quality Assurance Operations
Location: Somerville, Massachusetts, 02143, United States
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 recently 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.
The Quality Assurance Sr Manager is responsible for overseeing Finch Quality Operations focused, but not limited to, supporting the Quality Control Department. This position supports the day to day Quality Operations by providing quality oversight, support and guidance to Quality Control department and other staff and performing a variety of complex tasks under general guidance to ensure continued compliance to GxPs.
Responsibilities / Duties
- Support internal analytical activities including the quality operations for Finch’s internal Quality Control Laboratory and Donor Operations Program
- Lead, in conjunction with QA and QC senior management, the building/improving and maintaining of quality systems that are compliant with all applicable regulations and standards
- Perform routine reviews of analytical data and documents in support of Certificates of Analysis, raw material release, stability, and in-process testing in accordance with specifications and SOPs
- Ensure quality oversight of method transfers, method validations, specification setting/justification and related reports
- Review and approval of equipment qualification/validation documentation
- Manage quality events such as deviations, CAPA, OOS, and Change Control
- Oversee quality of GMP external laboratories supporting internal operations
- Create, implement and maintain SOPs, policies and procedures consistent with corporate and quality objectives
- Represent QA on cross functional teams with internal stake holders
- Conduct GMP training sessions as required
- Support other quality operations activities as needed
- Potential to supervise additional employees in the QA department
- Bachelor’s degree in science, or equivalent degree and experience
- 8+ years’ experience working in a pharmaceutical or biotechnology company
- Strong GxP knowledge and experience in implementing and managing quality operations
- Solid understanding of drug development and the manufacturing process
- Knowledge of current regulatory requirements related to GMPs
- Experience with oversight of analytical method validation, data integrity, out of specification investigations, and certificate of analysis approval
- Previous experience in Analytical Development or Quality Control prior to Quality Assurance is preferred
- Experience with CLIA certification and/or microbiology laboratories a benefit
- Ability to identify aberrant data and potential quality/compliance concerns escalating to senior management
- Strong team building/leadership skills and excellent communication skills
- Well organized, solid multitask abilities and must be able to perform under pressure/meet deadlines
- Ability to work independently, with minimal supervision.
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 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, 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.