Job Title: Temp Sr. Manager Compliance (Reg Affairs / Inspection Readiness / Quality Systems)-

Alt Job Title: RA Quality, Standards and Training Senior Manager

Location: Alameda, CA preferred but also open to REMOTE based while on contract

Type: Initial 6month contract

Description:

 The Regulatory Affairs Quality, Standards, and Training Senior Manager provides compliance oversight for the Global Patient Safety (GPS) and Regulatory Affairs (RA) function, with a primary focus on Regulatory Affairs activities. The role applies strong regulatory strategy knowledge to monitor, assess, and communicate performance against key compliance indicators, metrics, and inspection‑readiness standards. The Senior Manager drives process standardization and consistency by leading compliance monitoring activities, proactively identifying compliance and operational risks, and advancing continuous improvement initiatives. Working cross‑functionally with Clinical Operations, Clinical Development, and Quality Assurance, the role supports alignment to regulatory standards, mitigates compliance risk, and strengthens organizational inspection readiness.

Essential Duties/Responsibilities:

• Ensure accuracy of Reference Safety Information (RSI) trackers to include timely updates of submission dates and health authority approvals.
• Track RFIs to completion within the timelines as required per SOP
• Monitor aggregate report compliance to health authorities and CROs.
• Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs–related documents.
• Monitor Regulatory Affairs training compliance via LMS.
• Oversee the timely and accurate update of Regulatory Affairs SOPs by working with SOP owners.
• Ensure Regulatory Affairs points of contact for each study kept current with the health authorities.
• Monitor and analyze key compliance metrics to assess adherence to applicable procedures, regulations, and internal standards.
• Contribute to the development of leadership dashboards and slide decks summarizing compliance performance and trends.
• Support the investigation, tracking and timely closure of Quality Events, including root cause analysis and development of corrective and preventive actions (CAPAs), as required.
• Collaborate closely with SMEs to support deviation assessment and authorship, ensuring timely and high‑quality documentation.
• Coordinate with GPS and Regulatory Affairs SMEs to conduct impact assessments for new and evolving regulations and support development of implementation plans.
• Collaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a continuous state of inspection readiness.
• Author, review, and maintain procedures and standards relevant to Regulatory Affairs
• Partner with Corporate Training to maintain training matrices and ensure training requirements are current and aligned with procedural and regulatory expectations.

Compensation Details:

• Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
• The Pay Range for this position is $90.66 - $96.91 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). 

EEO and Reasonable Accommodation Statement:

Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

 By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.