Shattuck Labs (www.shattucklabs.com) is developing breakthrough therapies for immunotherapy, which harnesses the human immune system to improve survival for patients battling cancer and inflammatory disease. Shattuck has pioneered the development of dual-sided Fc fusion proteins with the Agonist Redirected Checkpoint (ARC) platform technology. Two compounds from the platform are currently being tested in clinical trials (SL-279252 and SL-172154). In multiple published studies, ARC therapeutics have significantly outperformed traditional antibody-based therapeutics, and we believe that the dual-functionality of the ARC platform positions our product candidates with best-in-class potential as compared to traditional antibody therapeutics. Over 300 product candidates have been generated from the ARC platform and are poised for IND-enabling studies. Shattuck Labs, based in Austin, Texas, is a privately held biotechnology company founded in 2016. The R&D hub for Shattuck Labs is based in Research Triangle Park, NC.
About the Position
The Director of Quality is responsible for compliance with GMP and GLP regulations, providing strategic input to CMC-related compliance activities, conducting audits of contract manufacturers and CMC-related vendors, providing leadership, management, and communication between and among Shattuck staff and its CMC-related vendors. This position will provide backup for GCP-related compliance activities. The right candidate may also be responsible for overseeing the QA group, supporting various compliance and risk management activities at Shattuck.
Summary of Key Responsibilities
• Develop and deliver robust procedures and processes for efficient quality oversight of CMC operations for clinical trial and future commercial product supply.
• Manage CMC vendor oversight of quality activities including but not limited to maintaining vendor compliance, audit scheduling, report writing, risk notification to management, vendor quality agreements.
• Create risk-based, compliance and business aligned strategies for phase-appropriate batch release operations.
• Provide routine updates to senior management, including escalation of issues.
• Work with senior management at Shattuck to fulfill staffing needs for the Quality Team, including potentially recruiting new staff or external consultants.
• In collaboration with the quality teams at CMC vendors, ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and adequately address root cause.
• Materials Control and Release: Ensure all required assessment and testing is carried out to support quality approval or rejection, as appropriate, for disposables, starting materials, packaging materials, intermediates, bulk and finished product.
• Create an environment of quality culture by setting an example and leading or facilitating the Shattuck training program for onboarding and continuous training.
• Take the lead in supporting Company quality by interacting with required representatives.
• Oversee the management of reported quality issues in accordance with Company procedures.
• In conjunction with senior management and other quality team members, drive the development and review of QA procedures, audit plans, checklists and other tools.
• Maintain the vendor qualification program (documentation, audits, etc.).
• Track and trend LIR/OOS, DEV, CAPA, change control and customer complaints and reports to senior management.
• Perform CAPA review, approval and effectiveness checks.
• Advise and counsel project team members and/or management on appropriate corrective and preventive actions to audit findings, policies and procedures, technical problem solving, and work methods.
• Participate in hosting audits and regulatory inspections in accordance with Company policies and procedures.
• Oversee the archive of all documentation related to, but not limited to SOPs, Specifications, MBRs, LIRs, OOSs, Deviations, CAPAs, Complaints, Change Controls, Equipment Qualifications or Validations, Methods and Protocols.
• Direct the scheduling and completion of internal facility and quality system audits.
Required Qualifications and Skills
• Degree (advanced degree preferred) in biochemistry, chemistry, chemical engineering or relevant scientific discipline.
• At least 10 years’ experience in GMP Quality or equivalent position, ideally with biological products.
• Thorough knowledge of and experience implementing GMP and GLP regulations and clinical manufacturing requirements for biological products. Familiarity with and experience in implementing GCP regulations is preferred.
• Prior direct involvement in multiple regulatory inspections of manufacturing facilities, and ideally also with clinical inspections.
• Experience in managing training programs.
• Proven ability to review and evaluate the content of various documents, including but not limited to CMC-related documentation, all documentation within a quality management system, standard operating procedures, policies.
• Proven ability to collaborate with other functional areas within the company.
• Proficient in reading, interpreting and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance.
• Excellent oral and written communication skills with strong technical writing experience required.
• Provides a vision and direction, initiates action and enables competence and effectiveness in others.
• Able to multi-task productively, applying time management processes and procedures effectively for on time delivery.
• Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem and working with others to correct problems.
• Works toward common goals by supporting, encouraging and sharing information with colleagues.
• Speaks, writes, listens and presents information in a logical and articulate manner.
Note to External Recruiters: Our Human Resources department manages all open positions and candidate recruitment. We kindly ask that recruiters not contact employees or hiring managers directly to present candidates or solicit business. Please note that we will consider failure to comply with this request when determining whether to enter into a professional relationship with a recruiting agency. Please also note that submission of unsolicited resumes does not create any obligations for Shattuck Labs, implied or otherwise.