Director, 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 Director, QA Operations will be responsible for leading the QA Operations team to support internal and external manufacturing, testing, packaging, labeling and disposition of Finch’s complete consortia microbiota, enriched consortia, and targeted consortia product pipelines, 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.
- Responsible for quality operations in support of Finch Manufacturing (internal manufacturing) and Contract Manufacturing Organizations (external manufacturing) and the QA systems
- Lead and drive accountability of a diversified team of Quality professionals responsible for cGMP manufacturing of early and late-phase clinical trial materials, including but are not limited to, materials, drug substance and drug product batch record review and lot disposition, and QA oversight of the construction, commissioning, qualification and validation (CQV) of a commercial manufacturing facility and the subsequent process validation activities
- Conduct management responsibilities in accordance with company policies and applicable laws. Recruit, coach and develop organizational talent to ensure scalable growth. Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Manage performance of personnel towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.
- Make and execute operational decisions with a strategic perspective
- Support operations in continuous improvement initiatives by providing direction on requirements for proposed changes
- Plan and manage QA Ops Budget
- Communicate strategic direction, quality policies/procedures and effectiveness of the Quality System at Management Reviews
- Promote a culture of quality and accountability mindset, including continuous improvement through the establishment of KPI metrics
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
- Prepare quality documentation, metrics, and reports by collecting, analyzing, and summarizing information and trends including failed processes, target turnaround times and disposition dates, number deviations per batch, Root Cause/CAPA activities, etc.
- Continually work to improve the effectiveness of QMS through the effective application of quality policies, objectives, audit results, analyses of data, and corrective/preventive actions
- Demonstrate effective change leadership by building strategic partnerships across functional areas to further departmental and organizational objectives.
- Provide support for internal and regulatory audits and inspections, as required
- Other duties as may be required, according to the changing needs of the business
- Bachelor’s degree in biology, biochemistry, or related sciences
- 12+ years’ experience working in a pharmaceutical or biotechnology company
- Previous experience managing teams in support of internal GMP manufacturing preferred
- 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
- Demonstrated experience in implementing and managing quality systems
- Strong leadership and communication skills with the ability to influence across functional teams
- 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 (temporarily closed due to COVID), fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap. 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.