Associate Director/Director Of Gcp Quality
By Thor Companies At San Francisco Bay Area, United States
•Management of GCP QA audit initiatives, quality systems, and provision of internal/clinical study team support
•Requires at least 8 years of prior managerial experience
•Bachelor's degree in a scientific field or equivalent qualification
Key areas of responsibility encompass:
•This position holds a direct reporting line to the Vice President of Quality
•Ensures proper and timely escalation of quality matters, including potential misconduct or significant deviations in projects/products
Clinical Documentation Specialist (Gcp Qa)
By Eikon Therapeutics At , Hayward, 94545 $107,000 - $123,000 a year
5+ years of experience in clinical documentation management.
Collaborate closely with Process, Documentation and Learning Management function, as required.
Strong project management; exhibits expertise in metrics analysis and reporting methodologies.
Demonstrated knowledge on Microsoft Office skills and well versed in industry trends and emerging technologies supporting documentation practices.
Establish and maintain curricula and learner roles in Veeva Vault training; create training requirements and release training assignments.
Sound working knowledge of Good Clinical Practice (GCP).
Gcp Data Engineer Jobs
By High5 At , Irving $60 an hour
Collaborating with cross-functional teams to understand data requirements and translate them into effective pipeline designs.
Working experience in Airflow DAG
Strong experience in designing and building ETL/ELT pipelines using GCP native tools or open-source technologies such as Python and PySpark.
Proven ability to work on a brand-new product/application, demonstrating adaptability and problem-solving skills in a dynamic environment.
Proficiency in SQL and experience working with various databases and data formats.
Excellent analytical and problem-solving skills, with the ability to troubleshoot and resolve complex data-related issues.
Gcp Data Architect Jobs
By Rinf At , Remote
Familiarity with GCP security features, including Identity and Access Management (IAM), Cloud Identity-Aware Proxy (IAP), and VPC Service Controls.
Implement and enforce security best practices and ensure compliance with regulatory requirements.
Strong experience in designing and managing Google Cloud Platform (GCP) services, including Compute Engine, Cloud Storage, Cloud Networking, BigQuery, and Dataflow.
In-depth knowledge of GCP technologies, architectures, and best practices.
Strong troubleshooting and problem-solving skills with the ability to analyze complex technical issues and provide timely resolutions.
Excellent communication and collaboration skills with the ability to work effectively in cross-functional teams.
Quality Manager – Gcp Jobs
By Foresee Pharmaceuticals At United States
•Demonstrated knowledge of Quality Management System tools, and continuous improvement methodologies.
•Lead the development, management and oversight of GCP related activities impacting the QMS.
•Prepare audit plans, perform and report audit findings to the auditee and Foresee management.
•Support risk management activities and lead GCP quality risk mitigation actions.
•Develop and present metrics as part of Quality Management Review meetings.
•Excellent knowledge of GCP and GPvP regulations. Experience with GMP and/or GLP is a plus.
Gcp Cloud Engineer (Entry Level) (Flexible Work Location)
By Caterpillar At , Nashville
Basic knowledge of Identity and Access Management
Job Duties/Responsibilities may include, but are not limited to:
Deploying or integrating cloud technologies based on requirements gathered from business partners
Experience developing automated solutions using Infrastructure as Code
Experience developing architectural designs, processes and procedures.
Certification in Google Cloud Platform
Sr. Gcp Qa Auditor - Remote
By Medpace, Inc. At , Raleigh, 27513
Develop audit management plans and audit strategy with clients for ongoing clinical trials.
5+ years of experience in a QA department in a related industry;
Experience conducting audits of vendors and investigative sites;
Experience hosting regulatory authorities and interacting with sponsor/client representatives;
Knowledge and application of Good Clinical Practice (GCP) is required;
Medical Device and or Phase 1 experience is a plus;
Director, Gcp Quality Assurance
By Cellectis At , New York
Develop and maintain appropriate TMF management process.
Maintain expert knowledge in regulatory requirements including cGCP principles
Technical Skills Requirements / Core Competencies
Manage and/or deliver yearly cGCP training for staff.
Experience as an Auditor within the GCP area preferred.
Experience in Oncology is preferred.
Associate Manager, Qa Gcp Auditor
By Regeneron At , Tarrytown
Reports findings to management with recommendations for resolution and verifies appropriate corrective actions have been implemented and documented.
Drafts and issues periodic reports to site management as requested
You have excellent interpersonal skills and ability to work with people in all levels of the organization and externally.
We seek candidates with proven skills in taking initiative and working independently
Good problem solving, written and verbal communication skills
Ability to effectively manage multiple priorities with a sense of urgency
Qa Gcp Auditor 2 Jobs
By IQVIA At , Remote
Evaluate audit findings and prepare and distribute responses to operations staff and management.
Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle.
Good interpersonal communication and organizational skills to establish and maintain effective working relationships with co-workers, managers and sponsors.
Good technology word processing, spreadsheets and database applications skills and knowledge of MS Office applications
Manage Quality Issues and serious breach investigations.
Associate Director, Gcp And Glp Quality Assurance
By Blueprint Medicines At , Cambridge
Strong experience in Quality Systems: CAPA, deviation, risk analysis and change control management.
Organizational Skills – Ability to balance multiple responsibilities and still meet high quality and timeliness standards under pressure.
Manage GCP inspection-readiness preparation for corporate Blueprint as well as CROs and investigator sites.
8 + years of demonstrated experience in Sponsor companies, CROs, GLP laboratories and/or GCP consulting.
Experience supporting Regulatory Authority GCP/GLP Inspections.
Relevant professional certifications are a plus.
Remote - Business Intelligence Analyst (Leadership Role) - Gcp
By CyberCoders At Denver, CO, United States
Ability to collaborate with business stakeholders and IT management to understand solution requirements and system design
Proficiency in management of multiple priorities to produce quality products for customers
10+ years of skills in building business reports as an Analytics Engineer.
Advanced knowledge of Google Cloud Platform components including but not limited to Cloud Storage, BigQuery, Google Sheets, DBT, Airflow/Composer and Dataproc.
High-level of experience with programming languages like Python
Expert SQL and data transformation knowledge.
Gcp/Bigquery/Looker Jobs
By Intone Networks At , Remote

Title: GCP/BigQuery/Looker Looking for Data Modeling / Data warehousing experienced professional. Mid-Sr Resource. Google Cloud experience , API integration, highlighted yellow will be plus. Must have ...

Director Or Sr Director Qa Gcp
By Erasca At , Remote $190,000 - $250,000 a year
10-12+ years of experience including management of GCP Quality in a pharmaceutical or biotech environment in progressively responsible Quality roles required
Develop metrics to support GCP activities and quality management review
Lead, manage, develop, and mentor direct report(s)
Experience with transition from Phase 1-3 to commercial quality systems is a plus.
Previous experience working with FDA and participating in regulatory agency inspections of clinical research activities
Excellent interpersonal and influencing skills
Gcp Operational Quality Senior Manager (Contract)
By Vertex Pharmaceuticals At , $85 - $95 an hour
In-depth knowledge of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks.
May serve as GCP Quality Management System representative
Typically requires 6 years of experience or the equivalent combination of education and experience
Ability to understand and translate customer needs, bringing a new perspective to existing quality management solutions
Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice (GCP).
Manages and/or leads domestic and international audits for Clinical Investigators, to ensure compliance to ICH GCP, applicable regulations, and company standards.
Director Of Gcp Quality Assurance
By BioPhase At San Diego, CA, United States
Working knowledge of quality risk management concepts
Internal trend analysis of audit observations; identifies and communicates to QA management all compliance risks
Ensures that the GCP Vendor Audit Schedule is created and approved by management
Experience auditing GCP vendors, internal GCP processes and documents and clinical investigator sites
Extensive knowledge and/or awareness of ICH GCP regulations and guidance for clinical and nonclinical development.
Knowledge of global regulatory standards and associated guidance’s/guidelines
Gcp Data Engineer Jobs
By Diamondpick At Nashville, TN, United States
Extensive hands on experience in developing the GCP applications
Experiencein DevOps is added advantage but not mandatory
Design and implementation of standards and best practices for applications built on GCP.
Document designs and standards and create application archetypes where possible for developer enablement.
Data Engineer (Aws, Azure, Gcp)
By CapTech At Tysons Corner, VA, United States
Learning & Development – Programs offering certification and tuition support, digital on-demand learning courses, mentorship, and skill development paths
Utilizing your skills in engineering best practices to solve complex data problems
Experience delivering solutions on a major cloud platform
Experience in the design and implementation of data architecture solutions
A wide range of production database experience, usually including substantial SQL expertise, database administration, and scripting data pipelines
Popular Certifications: AWS Cloud Practitioner, Microsoft Azure Data Fundamentals, Google Associate Cloud Engineer
Gcp Data Architect Jobs
By New York Technology Partners At Jersey City, NJ, United States
·Minimum 4 + years’ experience with data management strategy formulation, architectural blueprinting, and effort estimation.
·E2E Data Engineering and Lifecycle (including non-functional requirements and operations) management.
·Regulatory and Compliance work in Data Management.
·Good communication skills to understand business requirements.
·Good understanding and knowledge of Teradata/ Hadoop warehouse
·Experience in code deployment from lower environment to production.
Data Engineer (Aws, Azure, Gcp)
By CapTech At Chicago, IL, United States
Learning & Development – Programs offering certification and tuition support, digital on-demand learning courses, mentorship, and skill development paths
Utilizing your skills in engineering best practices to solve complex data problems
Experience delivering solutions on a major cloud platform
Experience in the design and implementation of data architecture solutions
A wide range of production database experience, usually including substantial SQL expertise, database administration, and scripting data pipelines
Popular Certifications: AWS Cloud Practitioner, Microsoft Azure Data Fundamentals, Google Associate Cloud Engineer