Temporary Senior Manager Compliance

Job Title :

Senior Manager, RA Quality, Standards & Training Location :

Alameda, CA Type :

6-month contract (renewable)

Compensation :

$80-100/hour (dependent on experience)

Contractor Work Model :

Remote or Hybrid for local candidates

Hours :

40.0 Responsibilities Provide compliance oversight for the Global Patient Safety (GPS) and Regulatory Affairs (RA) functions, with a focus on Regulatory Affairs activities. Monitor, assess, and communicate performance against key compliance indicators, metrics, and inspection-readiness standards. Drive process standardization and consistency by leading compliance monitoring activities, identifying risks, and advancing continuous improvement initiatives. Collaborate cross-functionally with Clinical Operations, Clinical Development, and Quality Assurance to ensure regulatory standards are met and inspection readiness is maintained. Ensure accuracy of Reference Safety Information (RSI) trackers, including submission dates and health authority approvals. Track RFIs to completion within SOP timelines and monitor aggregate report compliance to authorities and CROs. Maintain current and complete Trial Master Files (TMF) and Veeva RIM related documents, working with relevant teams. Monitor Regulatory Affairs training compliance through LMS and update SOPs appropriately. Support the development of compliance dashboards, trend analysis, and leadership reports. Support investigation, tracking, and closure of Quality Events, including root cause analysis and CAPA development. Assist in deviation assessments and document management with SMEs. Coordinate impact assessments for new regulations and assist with implementation plans. Support inspection readiness activities and partner with stakeholders to uphold standards. Maintain regulatory procedures and standards documents. Partner with Corporate Training to ensure training matrices and requirements stay current. Requirements Bachelor's degree in a related discipline; Master's degree preferred. 5-7 years of regulatory affairs experience in the pharmaceutical industry. Experience with audits and inspections is advantageous. Knowledge of regulatory frameworks, compliance metrics, and industry standards. Strong verbal and written communication skills, with ability to influence and collaborate effectively. Proven ability to manage multiple projects, prioritize tasks, and deliver high-quality results. Excellent analytical and problem-solving skills, with a proactive approach to workload and risk management. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M- #

LI- Ref:

#568-Clinical