Senior QMS Associate (Quality Docs and Training)

Job Description:
Seeking a highly skilled and experienced Senior QMS Associate with expertise in Veeva Vault Quality Docs and Training to join our Quality Assurance team. The successful candidate will play a key role in managing our Quality Management System (QMS), with a focus on document control, training management, and ensuring compliance with regulatory requirements.

Key Responsibilities:
Serve as the subject matter expert (SME) for Veeva Vault Quality Docs and Training modules, providing guidance and support to users across the organization.
Manage the creation, review, approval, and distribution of quality documents, including SOPs, work instructions, and forms, using Veeva Vault Quality Docs.
Develop and maintain training programs within Veeva Vault Training, ensuring that all employees receive appropriate training on quality procedures and regulatory requirements.
Coordinate training sessions, track training completion, and maintain training records in compliance with regulatory standards.
Collaborate with cross-functional teams to identify process improvements and streamline document control and training management workflows.
Support internal and external audits by providing documentation and training records as needed, and participating in audit activities as required.
Stay current on industry trends, regulatory requirements, and best practices related to quality management systems and Veeva Vault functionality.
Provide training and support to end-users on Veeva Vault Quality Docs and Training modules, including troubleshooting issues and answering user inquiries.

Qualifications:
Bachelor's degree in a scientific or related field; advanced degree preferred.
Minimum of 5+ years of experience in a quality assurance or quality management role within the biotechnology or pharmaceutical industry.
Extensive experience with Veeva Vault Quality Docs and Training modules is required.
Strong understanding of regulatory requirements (e.g., FDA, EMA) and quality standards (e.g., GMP, ISO) applicable to the biotech industry.
Excellent communication skills with the ability to effectively interact with stakeholders at all levels of the organization.
Proven ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.
Detail-oriented with strong organizational and documentation skills.
Certification in quality management (e.g., ASQ Certified Quality Auditor) is a plus.

**Compensation is variable based on background and level of experience**

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