Senior Manager, Quality Assurance Operations
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 Sr. Manager, QA Operations will be responsible for leading the quality operations team to support internal manufacturing, testing, packaging, labeling and disposition of Finch’s complete consortia microbiota product pipeline, including critical raw material, drug substance and drug product for multiple clinical programs. Fosters a quality and continuous improvement mindset to ensure the QMS in support of cGMP manufacturing is robust and compliant. Requires collaboration with cross functional teams in manufacturing, quality control, process development, analytical development, validation, quality and compliance, and regulatory affairs.
Responsibilities / Duties
- Develop, hire, and provide team leadership, including creating personnel development plans. Establish continuous learning and improvement programs, thereby ensuring team members are engaged and passionate about their work
- Manage a team responsible for materials, drug substance and drug product batch record review and lot disposition
- Promote a culture of quality and accountability mindset, including continuous improvement through the establishment of KPI metrics
- Track and trend batch execution, providing periodic updates to Management, e.g., target turnaround times and disposition dates, number deviations per batch, etc.
- Engage in activities to continuously assess and improve lot review and disposition processes
- Coordinate cross-functional deliverables to support material and product release
- Review and approve standard operating procedures and validation protocols and reports
- Review process development and analytical technical reports and verification of associated data
- Review and approve QMS documentation including controlled documents, training material, deviations, laboratory investigations, CAPAs and change controls
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
- Assist in authoring and review of general QA SOPs
- Provide support for internal and regulatory audits and inspections, as required
- Other duties as may be required
- Bachelor’s degree in biology, biochemistry, or related sciences
- 8+ years’ experience working in a pharmaceutical or biotechnology company
- Strong knowledge of regulatory compliance practices, FDA regulations 21CFR 210, 211, 11, 600, 1271, as well as applicable ICH and WHO Guidelines and international cGMP standards
- Solid understanding of drug development and manufacturing processes
- Experience with oversight of analytical method validation, data integrity, and out of specification investigations
- Previous experience in Analytical Development or Quality Control prior to Quality Assurance is preferred
- Strong teamwork and communication skills
- 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 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.
*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.