Overview
QA Automation Jobs in Remote at Garni Softwares Inc
Neurona Therapeutics is a clinical stage biotechnology company based in South San Francisco focused on the development of neuronal cell-based therapies for intractable neurological diseases. Neurona Therapeutics is seeking an exceptional candidate to join our Quality team. Our ideal candidate is a self-motivated individual who has a passion for clinical quality and can thrive in a fast-paced dynamic environment. The Director GCP Quality is responsible for leading Clinical Quality Assurance (CQA) activities for clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and significant experience in GCP and compliance, leadership, and communication skills to conduct responsibilities independently. This role is accountable for Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company’s Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines (e.g., United States FDA, European Union Directives, ICH, and National regulations).
Responsibilities:
Provide professional expertise and guidance on GCP, GLP and Good Pharmacovigilance Practices (GPV) regulations and other applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
Provides clinical quality strategy
Fosters a collaborative working relationship with key stakeholders (e.g., regional study team members, global clinical operations compliance team members, etc.)
Liaise with various Neurona functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk-based audit and compliance strategy for programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance
Independently manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP/GLP/GPV and Neurona policies and procedures; assess impact of audit findings on subject safety, data integrity, and business operations
Develop and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP/GLP/GPV and Neurona policies and procedures.
Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP/GLP/GPV, if they occur; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities
Lead and support GCP/GLP/GPV health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Neurona
Analyze, report, and present metrics for assigned programs to development teams, R&D, and Quality management; recommend any required actions and monitor implementation
Collaborate with Quality team to identify and mitigate GCP/GLP/GPV quality and compliance issues with potential impact across multiple programs or functional groups
Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution
Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriate
Other duties as assigned
Required Qualifications:
Extensive knowledge of ICH GCP, GLP and GPV and applicable FDA regulations and guidance for clinical development; knowledge of global regulations preferred
Demonstrated ability to analyze laws, regulations, and guidelines and apply them in practice
Strong at building cross-functional partnerships to meet strategic goals.
Proficient in critical thinking, CRO operations, and clinical trial systems.
Demonstrated ability in using continuous improvement techniques to contribute to a pharmaceutical QMS (e.g., Root Cause Analysis, etc.)
Experience with eDocument Management, Training, CAPA’s, Audit systems and tools
Detail oriented with strong written and verbal communication skills
Cell and Gene Therapy GCP experience preferred
Ability to work independently with minimal direction, within prescribed guidelines, or as a team member
Ability to work well in a deadline-driven environment
Travel may be required up to 25% of the time
Education Requirements:
BA/BS degree, preferably in biological sciences, or related field and at least 10 years of GCP-related Quality Assurance or relevant clinical trial and medical device experience.
Interested in learning more about our science and our team? Please visit our website at www.neuronatherapeutics.com.
Neurona is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
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Title: QA Automation
Company: Garni Softwares Inc
Location: Remote
