Job at a glance
Quality Compliance Manager Location: Alameda, CA About the Role We are seeking a Quality Compliance Manager to support GCP/GVP quality and compliance activities within a biotech, pharmaceutical, or clinical research environment. This individual will play a critical role in the planning, execution, tracking, and reporting of audit activities while ensuring the integrity and accuracy of quality records within Veeva Quality Vault.
The ideal candidate will possess hands-on experience with Veeva Quality Vault, a strong understanding of GCP/GVP regulations, and experience supporting clinical quality auditing programs. This role offers the opportunity to work cross-functionally with quality, regulatory, clinical operations, and compliance teams while contributing to continuous improvement initiatives. Key Responsibilities Support the planning, coordination, and reporting of GCP/GVP audit activities.
Assist with audit preparation, audit execution support, and audit closure activities. Track audit observations, findings, CAPAs, and related follow-up actions. Maintain accurate audit documentation and records in accordance with regulatory requirements and company procedures. Administer and manage audit-related information within the Veeva Quality Vault platform. Ensure timely entry and maintenance of audit reports, findings, and compliance documentation.
Support data migration and quality oversight activities within the Veeva Audit Module. Manage audit documentation and records retention processes. Partner with cross-functional stakeholders to collect, consolidate, and report audit-related information. Contribute to continuous improvement initiatives designed to enhance quality processes and compliance programs. Prepare status updates and communicate project progress to management.
Ensure quality records are inspection-ready and maintained to regulatory standards. Required Qualifications Bachelor's degree in Life Sciences, STEM, or a related discipline with a minimum of four (4) years of relevant industry experience; OR Six (6) or more years of related experience in biotech, pharmaceutical, clinical research, or a regulated industry in lieu of a degree. Minimum of 4 years of experience in biotech, pharmaceutical, CRO, or a related regulated industry.
Hands-on experience with Veeva Quality Vault on a daily basis. Experience supporting GCP and/or GVP audit programs. Experience with audit planning, audit reporting, and audit documentation management. Experience organizing and maintaining audit-related records. Familiarity with audit observation tracking and CAPA processes. Experience collaborating across multiple functional departments. Experience with the Veeva Audit Module.
Knowledge of Good Pharmacovigilance Practices (GVP). Experience supporting clinical quality assurance programs within biotechnology or pharmaceutical organizations. Exposure to regulatory inspections and inspection-readiness activities. Experience supporting global audit programs. Job Type & Location This is a Contract position based out of Alameda, CA. Pay and Benefits The pay range for this position is $55.00 - $60.00/hr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.
If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • E