Senior Manager, Quality Assurance Validation
3 weeks ago
At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
Ready to make your application Please do read through the description at least once before clicking on Apply.
We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Key Responsibilities & Accountabilities:
Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, and promotions, identifying opportunities and provide the means for employees to pursue career growth.
Provide quality guidance on process qualification, and continuous process verification strategies for gene editing components (i.e., oligonucleotide guide, CRISPR endonuclease, and ribonucleoprotein [RNP] complex) and ex vivo CRISPR gene-edited cell therapies manufactured internally and at CMOs.
Review and approve the Validation Master Plan (VMP) for manufacturing process, aseptic process, and shipping validation, working cross-functionally with key stake holders and responsible functions to ensure the defined VMP activities are executed, maintained and all supporting documentation is complete and accurate.
Perform quality review and approval of manufacturing process, aseptic process, and shipping validation protocols, performance, and final summary report.
Contribute to the development of procedures, business processes and tools for process qualification, and continuous process verification using industry best practices and adhering to industry standards.
Responsible as a key subject matter expert supporting development of process validation requirements and strategy for current and new product introductions through commercial scale.
Ensure relevant processes, equipment and systems are validated and the validated state is maintained throughout the equipment lifecycle.
Provide expertise to technical teams in the implementation of strategies for characterization and validation studies.
Manage the review and approval of quality control method validation protocols and associated reports.
Contribute to the development of strategies related to the design, installation, commissioning & qualification, and process qualification of digital manufacturing strategies.
Provide QA Validation support and expertise to CMC and Tech Transfer teams.
Represent the Quality Assurance Validation group in project teams, audits, and inspections.
Contribute to the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
Drive Support Continuous improvement and Operational Excellence initiatives.
Perform a wide range of managerial duties pertaining to employees including hiring, on-the-job training, career development, appraising performance, and promotions, identifying opportunities and provide the means for employees to pursue career growth.
Requirements
Knowledge, Skills & Capabilities:
Expertise in biologic cGMP manufacturing, with experience in cell and gene therapy preferred.
Demonstrated experience in execution of process validation programs from master plans through protocols and authoring reports.
Thorough understanding of industry guidance, knowledge of FDA, EMA and ICH regulations, and understanding of product development life cycle.
Experience in leading a team of direct reports and providing guidance and mentorship to junior team members.
Understanding of industry validation practices throughout the product lifecycle.
Proven ability to work independently as well as to collaborate and communicate effectively and work effectively in a team-oriented environment.
Working knowledge of current Good Manufacturing Practices (cGMP – 21 CFR Part 210/211) and Electronic Records; Electronic Signatures (21 CFR Part 11).
A minimum of eight (8) years of experience in pharmaceutical manufacturing, manufacturing science & technology, technical development or Quality.
Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.
Demonstrated ability to collaborate with both internal and external parties to achieve targeted objectives.
Demonstrated organizational skills to managing multiple projects and priorities.
Education & Relevant Work Experience:
BS Degree in Life Sciences or equivalent
Physical & Travel Requirements:
Travel 25% of the time
Benefits
Benefits Summary:
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.
-
Senior Director, GCP Quality Assurance
3 weeks ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
-
Senior Director, GCP Quality Assurance
2 weeks ago
Cambridge, United States Scholar Rock Full timeScholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGF?) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the...
-
Senior Specialist, Quality Assurance
6 hours ago
Cambridge, United States PepGen Full timeSr Specialist, Quality Assurance Position Summary The Sr Specialist Quality Assurance will be responsible for quality review of production and testing of clinical trial materials at external manufacturing site. Routine activities including review and approval of master batch records, executed batch records, analytical testing protocols, methods, reports and...
-
Manager/Senior Manager, GCP Quality Assurance
2 weeks ago
Cambridge, United States Apnimed Full timePOSITION SUMMARY: Make sure to apply with all the requested information, as laid out in the job overview below. The clinical quality assurance manager will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in...
-
Manager/Senior Manager, GCP Quality Assurance
3 weeks ago
Cambridge, United States Apnimed Full timePOSITION SUMMARY: The clinical quality assurance manager will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency...
-
Manager/Senior Manager, GCP Quality Assurance
3 weeks ago
Cambridge, United States Apnimed Full timePOSITION SUMMARY:The clinical quality assurance manager will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency...
-
Manager/Senior Manager, GCP Quality Assurance
3 weeks ago
Cambridge, United States Apnimed Full timePOSITION SUMMARY:The clinical quality assurance manager will provide support to ensure the quality and compliance of clinical studies conducted throughout Apnimed. This role will involve working cross functionally with internal and external stakeholders in support of CQA initiatives to ensure continuous improvement and quality in adherence to agency...
-
Quality Assurance Manager
1 week ago
Cambridge, United States Adaptimmune Therapeutics Plc Full timeAdaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate...
-
Quality Assurance Manager
1 month ago
Cambridge, United States Collabera Full timeJob DescriptionJob DescriptionTitle: Quality Assurance ManagerLocation: Cambridge, MADuration: 12+ monthsDescription:100% Onsite AMAM-F (8am - 5:00 pm, flexible)This role provides quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments. Potential scope of products...
-
Supervisor, Quality Assurance
1 hour ago
Cambridge, United States Vericel Corporation Full timeJob DescriptionJob DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing QA professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting...
-
Director, Quality Assurance
1 month ago
Cambridge, United States Adaptimmune Therapeutics Plc Full timeAdaptimmune 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 company...
-
Quality Assurance Manager
1 month ago
Cambridge, United States Collabera Full timeJob DescriptionJob Description Title:Quality Assurance Manager Location: Cambridge, MA Duration: 12+ months Description: 100% Onsite AMA M-F (8am - 5:00 pm, flexible) This role provides quality oversight with regards to the development and lifecycle management of test and inspection methods and fulfillment of regulatory commitments. Potential scope of...
-
Associate Director, Quality Assurance
4 days ago
Cambridge, United States Relay Therapeutics Full timeThe Opportunity:We are seeking a Quality professional to be a cornerstone to a growing and evolving Quality function at Relay Tx. You will partner with your Clinical Development colleagues to oversee several external contract vendors while simultaneously contributing and influencing the build of the Quality Management System as the team evolves along with...
-
Associate Director, Quality Assurance
3 days ago
Cambridge, United States Relay Therapeutics Full timeThe Opportunity: We are seeking a Quality professional to be a cornerstone to a growing and evolving Quality function at Relay Tx. You will partner with your Clinical Development colleagues to oversee several external contract vendors while simultaneously contributing and influencing the build of the Quality Management System as the team evolves along with...
-
Senior Product Quality Engineer
2 days ago
Cambridge, United States Draper Labs Full timeSenior Product Quality Engineer Job Location US-MA-Cambridge Requisition ID 2022-6483 Overview Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful and usable solutions. From military defense and space...
-
Quality Assurance Compliance Specialist
2 days ago
Cambridge, United States LanceSoft, Inc. Full timePOSITION TITLE: Quality Systems SpecialistLocation: Cambridge, MA ON SITE - 9am-5pm / Monday - Friday As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with CLIENT policies, QMS standards, and local regulations. You will report to the...
-
Quality Assurance Compliance Specialist
16 hours ago
Cambridge, United States LanceSoft, Inc. Full timePOSITION TITLE: Quality Systems SpecialistLocation: Cambridge, MA ON SITE - 9am-5pm / Monday - Friday As a Quality Systems Specialist, you will be responsible for providing effective and efficient support to the Quality Management Systems (QMS) team by maintaining compliance with CLIENT policies, QMS standards, and local regulations. You will report to the...
-
Quality Control Manager
1 month ago
Cambridge, United States Superior Nut Co Full timeQuality Control Manager - Cambridge, MASuccessful and growing Cambridge-Based Company with a strong Social and Environmental commitment to producing one of the finest food products in the world is currently looking for a passionate, motivated Quality Control Manager to join our Operations Team.The Company has acustomer base that includes all types of...
-
Validation Engineer
1 week ago
Cambridge, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: Collaborate with stakeholders to gather and define requirements for validation activities Design and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Perform risk assessments to identify critical and non-critical systems and validate...
-
Validation Engineer
3 weeks ago
Cambridge, United States Katalyst Healthcares and Life Sciences Full timeResponsibilities: Collaborate with stakeholders to gather and define requirements for validation activities Design and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Perform risk assessments to identify critical and non-critical systems and validate...
