Sr. Clinical QA Specialist
Be a part of the future of cloud at one of the fastest growing and profitable companies in enterprise software. Veeva is experiencing rapid growth and strong demand as the cloud software market is evolving toward industry-specific, cloud solutions. Veeva topped the Fortune Future 50 list of U.S. companies poised for breakout growth and was listed as one of the fastest growing companies among Forbes Fast Tech 25.
We build innovative SaaS solutions that span CRM, content management, and data for the life sciences industry. Our more than 675 customers ranging from emerging biotechs to the largest global pharmaceutical companies including Bayer, Lilly, Merck, and Novartis.We are driven by our core values: do the right thing, employee success, customer success, and speed. We are innovators, collaborators, and thought leaders out to create and bring to market solutions that help our customers improve and extend human life.
The Senior Clinical QA Specialist supports the Quality and Compliance function in developing its clinical quality systems/procedures and ensuring quality oversight over EDC implementation projects. QA responsibilities include, but are not limited to, documentation creation, editing and/or review for procedures related to application deployments, operations, and QMS.
- Interface with development, validation, and professional services staff to implement quality system strategies and plans, relevant to the defined role, which then
facilitatecontinuous QMS improvement.
- Assist in implementing and maintaining Clinical QA procedures and controls to ensure the QMS is compliant to current industry requirements.
- Assist in document control responsibilities for study related documents.
- Provide quality system management assistance within the regulations of clinical studies and quality standards, specifically: 21 CFR Part 312, 21 CFR Part 11, ICH E6 and ISO standards.
- Provide direct QA support related to nonconformance management (deviation program and CAPA program).
- Assist Corporate Compliance during Study Audits, Internal Audits, Sponsor Audits, or Regulatory Inspections; including the effective preparation of related documentation, providing accurate information and tracking of audit responses
- Responsible for creating and fostering mutually beneficial intradepartmental, cross-functional and organizational relationships to drive compliance to specified program objectives
- Bachelor’s degree in pharmaceutical sciences or other related scientific disciplines.
- Minimum five (5) years of experience in a regulated industry with at least three (3) years of experience in pharmaceuticals, clinical research, and/or medical device.
- Prior experience of development and maintenance of a QMS system and operational experience.
- Knowledge and understanding of 21CFR Part 11, 21CFR Part 312, ISO standards, and Good Clinical Practices (ICH E6 GCP), Good Documentation Practices (GDP) and Good Manufacturing Practices (GMPs).
- Good working knowledge of CAPA/deviation processes, investigational methodologies
- Proficiency in MS Office
- Familiarity with Agile Software development
- Computer Systems compliance and validation
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