Manager, Document Control
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 Document Control Manager will be responsible for the development and implementation of the GxP document control system and processes, including the implementation and management of the Electronic Document Management System (EDMS), and the development and management of direct reports. Fosters a quality and continuous improvement mindset to ensure a compliant GxP Document Control System in support of research and development, in-house manufacturing and testing, out-source manufacturing (CDMO), and out-source contract testing (i.e.., CROs, contract labs). In addition, this role will be responsible for providing training and guidance to users on the EDMS and procedures, as applicable.
The Document Control Manager will be a champion for quality documentation principles and compliance for the organization.
Responsibilities / Duties
- Provide leadership for the Document Control department.
- Manage, develop and mentor staff within Document Control department.
- Create and implement compliant documentation policies, standards, and procedures for the Document Control System and processes.
- Manage and execute the initiation, processing, routing, distribution and archiving of GxP documentation and direct the compliance of documentation. Ensure compliance with controlled document format and content
- Manage and monitor the processing, review, and approval of all revision‑controlled documents in the Electronic Document Management System (EDMS)
- Provide user assistance and training on the EDMS
- Maintain master documents and records (both hardcopy and electronic) to ensure documentation is retrievable and files are accurate, complete, and well organized
- Manage the document periodic review process
- Responsible for managing record retention policies and procedures
- Issuance of batch records, logbooks, validation protocols, labels, and other controlled documents
- Assist with generating Quality Document Control metrics
- Provide support for internal and regulatory audits and inspections, as required
- Serve as a subject matter expert for the electronic document management system to internal and external stakeholders
- Represent Document Control on project-related teams
- Conduct continuous improvement of the Document Control program
- Perform other duties as applicable
- Bachelor’s degree, preferably in the Life Sciences
- A minimum of 6-8 years of relevant pharmaceutical/biotech industry experience including a minimum of 4 years of direct document management experience
- Direct experience with, and technical knowledge of, the administration of an electronic document management system (EDMS), i.e., Veeva Vault, MasterControl, etc., is required
- Excellent computer skills and knowledge of MS Office and Document Management systems
- Experience in providing guidance on compliance issues relating to document change management, and familiar with and able to interpret relevant regulations (e.g. FDA, Health Canada, etc.)
- Strong teamwork and communication skills and the ability to follow written and verbal instructions
- Ability and desire to work in a fast-paced and dynamic environment
- 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 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.