Senior Compliance Specialist
Location: Somerville, Massachusetts, 02143, United States
Senior Compliance Specialist
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 Senior Compliance Specialist will be responsible for the performance of a wide variety of activities to ensure compliance with applicable domestic and international regulatory and cGMP requirements, e.g., assist with inspection readiness and regulatory agency inspections, conduct supplier audits, manage complaints and investigational product retrievals, assist with KPI tracking and trending, develop internal audit schedule and/or conduct internal audits, plan quality management reviews, manage Complaints, CAPAs, Change Controls, Deviations, and etc.
The Senior Compliance Specialist will be a champion for regulatory principles and best practices and will continuously monitor for new cGMP regulations to ensure Finch’s Quality Management Systems (QMS) is at a constant state of compliance.
Responsibilities / Duties
- Plan and lead Internal and External (Supplier) audits
- Lead or support Supplier quality activities, including supplier assessments, evaluations, audits, supplier change notifications and supplier corrective actions
- Responsible for timely and effective execution of both internal and external audit commitments
- Lead the audit team for the regulatory inspections and/or third-party audits
- Serve as system administrator for CAPAs, Change Controls, and Deviations
- Manage Complaints and investigational product retrievals and/or product recalls
- Interact with SMEs in all functional areas to manage their response to any findings and their timely commitment to address those findings within CAPA and other quality systems
- Responsible for tracking and trending of Quality System KPIs
- Analyze compliance performance trend and be able to set up the metrics for measurement of compliance risk and be able to drive initiatives to mitigate those risks
- Partner with Regulatory to assess new or revised regulations and standards. Be able to update current procedures and provide guidance to other functional areas to ensure compliance
- Participate and serve as Quality Lead in system, process, product, and program improvement teams
- Perform other duties as applicable
- 15% travel or more is required
- Bachelor’s degree in Regulatory & Compliance, Science or related technical field
- 6+ years of quality, process development and/or manufacturing experience in biotech or pharmaceutical industry
- Proven knowledge of FDA regulations and ICH Guidelines, e.g., 21 CFR Parts 11, 210 and 211, 600, ICH Q6, Q7, Q8, Q9, Q10, etc.
- A thorough understanding of Quality Management Systems and tools in cGMP environment
- Demonstrated ability to evaluate and apply regulatory requirements to applicable situations, and be able to make sound justification and decision based on available data and risk
- Continuous improvement mindset and/or experience to help identify gaps and actively close those gaps by initiating and managing related projects
- Strong understanding of quality processes including change control, process control, risk assessment and management, and root cause analysis
- Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
- Strong organizational and time management skills. Prioritization and problem-solving skills
- Drive change, efficiency, and strong cross-functional relationships
- Ability to influence and demonstrate strong command to achieve outcomes
- Ability and desire to work in a fast-paced and dynamic environment
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.