- Develop and maintain the GMP/GDP specific aspects of the KalVista Quality Management System to meet country specific requirements (U.S.)
- QA lead for country level inspections
- Conduct/oversee audits of GxP vendors
- Conduct of internal audits as required
- Support Quality Oversight of US 3PL vendors, including review of Quality Technical Agreements, attending Quality Meetings, QA oversight of GxP quality issues, returns, destructions
- Support recalls and mock recalls
- Act as QA assessor/reviewer of GMP/GDP Change Controls
- Develop, utilize and continue to mature QA tools
- Author/Revise Standard Operating Procedures
- Additional activities to support the wider aims of the QA department
- Support initiatives associated with inspection readiness
- Support initiatives associated with the design and implementation of the commercial supply chain
- Act as designated person in U.S. for QA (including U.S State Licensing activities)
- 8+ years experience working in Quality Assurance (GCP, GMP and GDP compliance)
- Good communicator with the ability to lead and challenge the status quo
- Ability to plan work and prioritize task to meet tight deadlines
- Bachelor's degree required
- Excellent interpersonal and communication skills
- Two days (2) per week on-site office presence
-
Quality Assurance Specialist
3 weeks ago
DPS Group Boston, United StatesADPS Group is seeking a Quality Assurance Specialist to support leading and owning risk assessments in support of change controls and deviations. The scope of work will require writing risk assessment documents and holding stakeholder meetings to progress risk assessments and obt ...
-
Quality Assurance Specialist
1 week ago
Deephealth Somerville, United States**Job Description**: · Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, RadNet is _Leading Radiology Forward_. With dynamic cross-training and advancement opportunities in a team-focused environment, the core of RadNet's succ ...
-
Quality Assurance Lead
1 week ago
Elegant Enterprise Wide Solutions, Inc Boston, United States**Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...
-
Quality Assurance Manager
5 days ago
RADcube Boston, United States**Quality Assurance Manager**: · **Type**:Contract | **Location**:Boston, Massachusetts · Primary Responsibilities · - Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. · - Track, measure, and report on progress ...
-
Quality Assurance Lead
1 week ago
Elegant Enterprise Wide Solutions, Inc Boston, United States**Minimum Requirements** · - Five (5) years of experience in quality assurance, vendor management, and/or technology design/testing/implementation/operation. · - Experience with developing, implementing and/or overseeing test plans and test reports. · - Effective organizational, ...
-
Quality Assurance Test Manager
3 weeks ago
NavitsPartners Cambridge, United States**Position**: Quality Assurance Test Manager · **Duration**: 18-24 months · **Hours Per Week**: 37.5 · **Location**: Hybrid (Boston, MA) · **Position Summary**: · **Quality Assurance and Test Management**: · - Plan, execute, and lead testing efforts to ensure compliance with PROG ...
-
Quality Assurance
2 weeks ago
Global Pharma Woburn, United States**Title: Quality Assurance** · **Location: Woburn, MA** · **Duration: 09 Months** · Client is a profitable technology company headquartered in Woburn, Massachusetts, USA. Client has developed a proprietary and patented Adaptive Focused AcousticsTM (AFA) technology platform which ...
-
Aerospace Quality Assurance Specialist
1 day ago
Smithsonian Astrophysical Observatory Cambridge, United States**Description**: · **OPENING DATE: June 3, 2024** · **CLOSING DATE: June 28, 2024** · **TYPE OF POSITION: Trust Indefinite (Non-Federal)** · **DIVISION: Central Engineering** · **LOCATION: Cambridge, MA** · **What are Trust Fund Positions?** · Trust Fund positions are unique to t ...
-
Quality Assurance Testing Lead
2 weeks ago
Global Atlantic Financial Group Opportunities Boston, United States**COMPANY OVERVIEW** · Global Atlantic Financial Group is a leader in the U.S. life insurance and annuity industry, serving the needs of individuals and institutions. Global Atlantic is a wholly-owned subsidiary of KKR, a leading global investment firm that offers alternative ass ...
-
Contract - Quality Assurance Specialist, Cmc
2 weeks ago
Vedanta Biosciences Cambridge, United States**Title: Contract - Quality Assurance Specialist, CMC** · **Location: Cambridge, MA and Acton, MA** · **Reports to: Supervisor, Quality Assurance** · **About Vedanta Biosciences**: · **The Role**: · The QA CMC Specialist is responsible for performing a wide variety of activities ...
-
Ct Quality Assurance Specialist
1 week ago
Brigham & Women's Hospital(BWH) Boston, United States**CT Quality Assurance Specialist** · Reporting to the Assistant Clinical Director (ACD), of CT the Quality Assurance Specialist facilitates the CT Quality Assurance program and provides appropriate education to the staff which includes assessing, planning, implementing, and eval ...
-
Training and Quality Assurance Manager
4 days ago
Pine Street Inn Boston, United States**SCHEDULE**:40 hours, Monday - Friday, 8:00 a.m. - 4:30 p.m. (some evenings and weekends as needed) · **LOCATION**:Remote (with Travel) · **The Electronic Health Record Specialist is a non-essential position in the event of emergency or weather and will work 100% remote at this ...
-
Director of Quality Assurance
6 days ago
Harba Solutions Inc. Cambridge, United StatesResponsibilities · Recruit, develop, and motivate staff to ensure effective departmental functions and maintain managerial and specialized skills. · Provide coaching and mentoring to staff, focusing on job performance and career development, including training, feedback, rewards, ...
-
Quality Assurance Reviewer Associate I
3 weeks ago
Commonwealth Care Alliance Boston, United States**Why This Role is Important to Us**: · **Position Summary**: · Reporting to the VP Quality & Controls Assurance, the incumbent is responsible for independent quality reviews of medical claims, and evaluating Call Center activities for compliance with policies and Standard Operat ...
-
Quality Assurance Specialist I
1 week ago
Catalent Chelsea, United States**We're hiring for a rotating night shift Quality Assurance Specialist I to provide QA support for cGMP manufacturing activities, at our facility in the Boston area** · Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ...
-
Emerald Enterprises Cambridge, MA, United States FreelanceAre you looking to take the next step in your career? At Brunel, you have the opportunity to continuously develop yourself with renowned clients across industries. Take the decisive step in your career today and apply with us as a Project Manager for Automotive Quality and Produc ...
-
Supervisor, Quality Assurance
2 weeks ago
Vericel Corporation Cambridge, United StatesJob Description · Job 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 establi ...
-
Fare Systems Quality Assurance Lead
2 weeks ago
Novalink Solutions LLC Boston, United StatesThe Fare System Quality Assurance Lead – Fare Transformation will have overall responsibility for compliance demonstration, quality assurance, and defect resolution for the new MBTA fare system. They will lead test strategy, monitor vendor's progress towards demonstrating complia ...
-
Quality Assurance
2 weeks ago
Lazarusai Cambridge, United StatesLazarus AI creates dynamic, highly accurate machine learning APIs to solve the data extraction and data activation challenges of our customers. Our latest innovation, RikAI, is a large language model that extracts data from any document without training, regardless of type, forma ...
-
Vertex Pharmaceuticals Boston, United StatesJob Description · General Position Summary: · The Audit and Inspection Management Manager is responsible for the execution of audit and inspection management assigned activities, inclusive of internal and external processes, contributing to and executing audit plans, supporting i ...
Associate Director, GxP Quality Assurance - Cambridge, United States - Kalvista Pharmaceuticals
Description
About KalVista Pharmaceuticals, Inc.KalVista Pharmaceuticals, Inc.
) is focused on the discovery, development, and commercialization of novel, oral therapies for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE).
Listed on the Nasdaq Global Market, our headquarters is located in Cambridge, MA with additional offices and laboratories in Salisbury, UK; Zug, Switzerland; and Salt Lake City, UT.
The company has an R&D team with an established track record in the pharmaceutical development of small molecule protease inhibitors, world-leading expertise in the role of plasma kallikrein in disease, and a management team with the capability to bring small molecules through the clinic to commercialization.
KalVista seeks an Associate Director, GxP Quality Assurance, which is critical to the organization's mission as it prepares to commercialize sebetralstat, a novel, oral plasma kallikrein inhibitor.
KalVista recently reported positive results from the KONFIDENT Phase 3 study which demonstrated that sebetralstat met all primary and secondary endpoints for the on-demand treatment of HAE attacks and the safety profile was comparable to placebo.
The Company plans to submit a new drug application to the U.S.Food and Drug Administration (FDA) in the first half of 2024 and expects to file for approval in Europe and Japan later in 2024.
About the role:
The Associate Director, GxP Quality Assurance will be an integral part of the Quality Assurance function acting as primary QA contact for GxP consultancy and support for the U.S.
Responsibilities:
Requirements:
&v=024){kind=logo}
