- 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
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Associate Director, GxP Quality Assurance - Cambridge, United States - Kalvista Pharmaceuticals Inc
Description
Job Description
Job DescriptionAbout 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. (covering Research & Development, Supply Chain and Commercial).
Responsibilities:
Requirements:
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