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Ginkgo Bioworks
Boston, MA, United States
The Corporate Quality Team is responsible for the overall Quality across Ginkgo. We focus on the defining and measuring Quality, QMS (Quality Management System) implementation, training, maintenance and continuous improvement. The QMS is the foundation to Ginkgo’s quality culture as it includes quality issues escalation process, internal and exter
Job Source: Ginkgo BioworksTScan Therapeutics
Waltham, MA, United States
Career Opportunities with TScan Therapeutics A great place to work. Careers At TScan Therapeutics Current job opportunities are posted here as they become available. TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Dir/Sr.
Job Source: TScan TherapeuticsOlema Oncology
Boston, MA, United States
Who We Are >>> Why You Should Work With Us Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women's cancers. Olema's lead product candidate, palazestrant (OP-1250), is a proprietary, orally-available small molecule with dual activity as both a com
Job Source: Olema OncologyAdaptimmune Therapeutics PLC
Cambridge, MA, United States
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our
Job Source: Adaptimmune Therapeutics PLCSci-Rec
Boston, MA, United States
Head of Quality Assurance - Boston Do you want to join a growing biologics CDMO based in Boston, MA and help the team to achieve their site goals of considerable growth over the next 5 years? If so, apply below. Responsibilities: Maintaining site's Quality system in accordance with regulatory guidelines and cGXP compliance requirements; Maintaining
Job Source: Sci-RecSci-Rec
Boston, MA, United States
Head of Quality Assurance - Boston Do you want to join a growing biologics CDMO based in Boston, MA and help the team to achieve their site goals of considerable growth over the next 5 years? If so, apply below. Responsibilities: Maintaining site's Quality system in accordance with regulatory guidelines and cGXP compliance requirements; Maintaini
Job Source: Sci-RecRBW Consulting
Boston, MA, United States
RBW is partnering with an innovative biopharma company in its search for a Director of Quality. Our client has several biologics products on the market, with a strong development pipeline and is providing the right candidate with the opportunity to work with a rapidly growing organisation. The candidate will report directly to the executive team,
Job Source: RBW ConsultingPirouette Medical
Boston, MA, United States
[Full Time] Director of Quality Assurance at Pirouette Medical (United States) | BEAMSTART Jobs Director of Quality Assurance Pirouette Medical United States Date Posted 31 Oct, 2022 Work Location Boston, United States Salary Offered $150000 — $200000 yearly Job Type Full Time Experience Required 6+ years Remote Work Yes Stock Options No Vaca
Job Source: Pirouette MedicalWaltham
Job Description Job Description Position Summary:
TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Dir/Sr. Director of Quality to lead Quality Assurance for in-house and virtual GMP operations supporting the company’s novel TCR-engineered T cell therapy products. This role will reside within Technical Operations and Quality and will report to the Senior Vice President of TO&Q. Key activities will include supporting efforts for near term IND submissions and clinical manufacturing, identifying and hiring key talent to expand the department, building a compliant and flexible QMS, and defining growth plans to meet the company’s mid- and long-term strategic initiatives.
The ideal candidate: (i) will have a strong background in Quality and firm understanding of the cGMPs and ICH guidelines related to the manufacture and testing of human cell and gene therapy products, orphan drugs, or other complex and novel dosage forms; (ii) will be an exceptional manager and leader, (iii) will be a steadfast problem solver who thrives in a fast-paced, lean and agile environment; and (iv) is a team player who can foster productive relationships with internal colleagues and with external partners.
Responsibilities:
Build and manage TScan’s Quality Assurance team
Oversee development of personnel within the quality department, building a strong team and clear vision to drive best in class performance
Continue to build and manage TScan’s Quality Management System
Provide strategic leadership to the Quality operations group for sustained quality system programs with a continuous focus on improvement
Collaborate with the Heads of Pre-Clinical and Clinical development to manage all GxP operations
Oversee Quality Operations including lot disposition, incoming receipt, QA on the floor, and run the Material Review Board
Direct Quality Systems including document management, change control, exception management, CAPA, and training
Coordinates and executes periodic Quality Management Reviews and trend analysis of all aspects of cGMP operations
Manage audits and inspections by clients, FDA, and other regulatory agencies
Work with supply chain, external suppliers, and contract labs to ensure compliance and quality, including management of audits and quality agreements
Identify and initiate improvements to the quality management system, ensuring compliance to all relevant quality standards and regulatory requirements
Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate
Ensures the company is in a constant state of inspection readiness across all functions through continuous education, training, and internal audits
Prepare the QA function to support registrational trials and ultimately commercial activities
Ensure timely release of clinical and commercial product batches
Requirements:
15+ years of relevant experience; degree emphasis in biological sciences, biochemistry, cell biology, or related field is preferred
Strong background in Quality Assurance and Compliance, both FDA and EU regulations
Experience dispositioning Drug Product for use in Clinical and Commercial
Proven ability to build and develop strong teams, as well as robust and flexible systems
Creativity, critical thinking, ability to innovate, and problem solving
Excellent communication skills (both written and oral)
Significant experience drafting manufacturing documentation and supporting documentation for regulatory filings
Experience in cell and gene therapies strongly desired.
About TScan:
TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScan’s discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.
Do YOU have the anatomy of a TScanner?
Our talented, compassionate, and intelligent team is what makes TScan a great place to work. Our brand-new offices with approximately 40,000 square feet of premium lab and office space is an environment that supports innovation, camaraderie and professionalism. We are driven, passionate, fun, flexible and team oriented. Sound like you? Apply today.
Email Alert for Senior Director, Quality Assurance jobs in Waltham
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