- Develop and coach team members for fostering a collaborative environment and enabling performance.
- Ensure timely delivery of final product through performance of disposition activities.
- Serve as Quality Point-of-Contact for a client program.
- Provide on-the-floor QA oversight and support in the GMP cleanroom to ensure compliance to GMP regulations throughout the manufacturing areas.
- Perform receipt and disposition of incoming patient apheresis material.
- Perform issuance verification of production documents and labels, to meet production schedule.
- Ensure products are manufactured in compliance with regulatory and GMP guidelines.
- Ensure all product-related Deviations are initiated, investigated, and resolved.
- Ensure that associated CAPAs are initiated and resolved.
- Perform review of quality records including lab investigations, work orders, and change controls.
- Ownership of quality records such as impact assessments, major deviations, CAPAs and change controls.
- Identify compliance risks and escalate the issues to appropriate levels of management for timely resolution.
- BA/BS degree with 7+ years of experience in a pharmaceutical, biotechnology or biologics operation with 5 of those being within Quality.
- 2+ years of experience managing a team
- Experience in Viral Vectors, Cellular and Gene Therapy Products is desired.
- Working knowledge and ability to apply GMPs.
- Strong teamwork and collaborative skills.
- Experience with manufacturing investigations, deviations, and CAPA.
- Experience with change control practices and strategies.
- Strong knowledge with aseptic manufacturing processes is preferred.
- Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.
-
Manager, Quality Assurance Operations
1 week ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Editas Medicine Waltham, United StatesAt 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 CRI ...
-
Editas Medicine Watertown, United States PermanentAt 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 CRI ...
-
Sr Director Quality Assurance Operations
1 day ago
Insmed Bridgewater, United StatesCompany Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated ...
-
Sr Director Quality Assurance Operations
2 weeks ago
Insmed Incorporated Bridgewater, United StatesCompany Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicate ...
-
Sr. Manager GCP quality Assurance
1 week ago
Planet Pharma Watertown, United StatesJob Description: · Playing a critical role , the Sr. Manager, GCP Quality Assurance will be relied upon as Subject Matter Expert in providing GCP Quality Assurance and Compliance support with respect to planning, execution and close-out of clinical programs. The Sr. Manager, GCP ...
-
Senior Quality Engineer
3 weeks ago
Exergen Corporation Watertown, United StatesExergen Corporation is the recognized world leader in medical non-invasive temperature technology. Exergen invented and manufactures non-invasive temperature measurement devices providing lower cost, higher accuracy, less invasiveness, and greater reliability than ever previously ...
-
Hair Stylist Intern
4 days ago
Great Clips Watertown, United StatesAre you a cosmetology or barber student who's ready to jump-start your career? Join a locally owned Great Clips salon team and they will help you develop your skills and gain essential salon experience. · Have you always wanted to do hair? Can't afford beauty school or didn't fi ...
-
CNC Machine Operator
3 weeks ago
Doherty Staffing Solutions Watertown, United StatesTake the next step in your machining career with this job in Watertown, South Dakota Doherty Staffing Solutions is partnering with a leading manufacturing team in Watertown, SD. We're seeking candidates for CNC Machine Operator roles on 1st shift (5:00am-3:30pm, Monday-Thursday). ...
-
Manufacturing Engineer Manager
3 weeks ago
Allied Motion Technologies Inc. Watertown, United StatesAllient Inc. is in growth mode and currently seeking a Manufacturing Engineer Manager to join our team Allient Inc. is a global publicly traded company with over 2200 employees at 26 locations in 11 countries. The Manufacturing Engineer Manager is responsible for developing and i ...
-
Senior Director, Clinical Data Management
3 days ago
C4 Therapeutics Watertown, United StatesAbout C4 Therapeutics: · C4 Therapeutics (C4T) (Nasdaq: CCCC) is a clinical-stage biopharmaceutical company dedicated to delivering on the promise of targeted protein degradation science to create a new generation of medicines that transforms patients' lives. C4T is leveraging i ...
-
Die Cast Remelter
3 days ago
Twin City Die Castings Watertown, United States Full timeAt TCDC, you are not a number - you are part of a team that owns its future TCDC is an employee-owned company with over 100 years in business and three locations. We value our employer owners and their contributions that play an important part in our ability to provide our custom ...
-
Watertown Regional Medical Center Watertown, United States Full timeDescription · $10,000 Sign On Bonus with 2 year agreement - lump sum pay out within 30 days of start · Full Time .9 FTE; three 12 hours shifts per week - every 5th weekend rotation · The Senior Behavioral Health Registered Nurse provides individualized psychiatric nursing care ...
-
Sr Director Quality Assurance Operations
1 week ago
Insmed Incorporated Bridgewater, United States Full time· Company Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedica ...
-
Clinical Quality Manager
1 week ago
BostonGene Waltham, United StatesPosition Summary · BostonGene is seeking a Clinical Quality Manager to join our Quality Assurance team. In this role the candidate will be responsible for coordinating and facilitating Quality Assurance standards based on CAP/CLIA and Good Clinical Lab Practice (GCLP) regulatory ...
-
Credit Risk Analyst
1 week ago
C&L Group Waltham, United StatesDescription · Provide analytical support in executing internal control discipline and operational excellence within a LOB/ECF. Gather and organize data in order to monitor and test the effectiveness of key controls and status of mitigation and action plans. Prepare documentation ...
-
Medical Device Quality
1 week ago
Client of Nachman BioMedical Waltham, United StatesGreat QA/RA Project Management opportunity with a well-established and growing developer of a range of specialized medical temperature sensing devices for clinical and consumer settings. The experienced and successful QA/RA Project Manager in this new role will report to the VP o ...
-
Sr. QA Specialist
6 hours ago
Thrive Waltham, United StatesA Pharmaceutical client is looking for a Senior Quality Assurance Specialist , specifically with documentation experience in biotechnology or pharmaceutical industry · Job Overview · Senior QA Documentation Specialist, you will be instrumental in the management and evolution of ...
-
Computer Systems Engineer
4 weeks ago
GForce Life Sciences Waltham, United StatesResponsibilities · • Perform validation activities supporting requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary repo ...
-
Quality System Supervisor
1 week ago
BostonGene Waltham, United StatesPosition Summary · BostonGene is seeking a Quality Systems Supervisor to join our QA team. This role will integrate and manage quality assurance activities across all business units, which includes pre-analytical, analytical, and post-analytical groups under Laboratory Operations ...
Manager, Quality Assurance Operations - Watertown, United States - ElevateBio
Description
ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.
The Role:
ElevateBio is looking for a Viral Vector Manager, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Manager will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events. This individual will manage a team of QA professionals and engage with other members within operational departments as a Quality partner by providing real-time support to achieve on-time closure of quality records and disposition. A successful candidate in this position has thorough understanding of cGMP, solves problems by applying a combination of best practices and creative solutions, proactively identifies opportunities for new initiatives, and serves as a subject matter expert within Quality related functions.
Here's What You'll Do:
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms - including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform - with BaseCamp, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.
We aim to be the dominant engine inside the world's greatest scientific advancements harnessing human cells and genes to alter disease.
Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
