Principal/Senior GxP Systems Analyst
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.
As a member of the IT team at Finch Therapeutics, you will partner with the organization and be a key contributor in a variety of IT projects with a focus on delivering new GxP applications and systems. This is an opportunity to provide support and leadership on key strategic business initiatives at a time of high growth. If you enjoy working in a fast-paced and rapidly growing environment, this could be the opportunity for you!
- Participate in cross-functional teams to plan, design, and implement new GxP systems, acting as a business partner and sometimes as a leader or project manager.
- Work with Quality and business owners to install new GxP systems or perform upgrades to existing GxP systems.
- Collaborate with the QA organization to develop and execute scalable, risk-based computerized systems validation (CSV) processes and procedures.
- Perform regular security audits of GxP systems.
- Interface effectively with system business owners, Quality and associated vendors.
- Engage appropriate SMEs as needed to drive resolution to incidents and problems.
- Resolve GxP computer system issues in coordination with Quality and business users.
- Make recommendations to improve and optimize existing GxP systems
- Review and collaborate on GxP Systems Development Life Cycle documents and GxP Systems SOPs
- System administrator for user account management & security for GxP systems
- 5 to 10 years of professional experience
- Experience in the life sciences industry and working knowledge of FDA and/or EU regulated environments. Other industry compliances may be a possible substitute for this qualification.
- Experience with Veeva (RIM, QMD, QualityDocs, Training, eTMF) preferred. Varied experience with GCP, GMP, and GEP systems is beneficial.
- Strong Business Systems Analyst skills, ability to document business processes and use cases.
- Experience with cloud and Software-as-a-Service (SaaS) delivery models.
- Experience with Change Control, incident response and release management
- Previous experience working with Quality stakeholders to validate GxP solutions for intended use
- Ideally familiar with GAMP5, Annex 11 or 21CFR Part 11
- Working knowledge of IT security best practices
- Ability to explain technical concepts to technical and non-technical audiences
- Ability to work creatively and analytically to solve business problems
- Comfortable under high-stress and exhibits poise and focus
- Strong verbal and written communication skills
- Skilled in project management and general troubleshooting
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, 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.
*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.