Clinical Trials - Sr. Regulatory and Quality Manager
Bring your clinical trials regulatory and quality experience to the Clinician Trials department of the nation’s leading not-for-profit, integrated health. Become an integral part of an incredible team, providing industry expertise in all areas related to clinical trials, regulatory and quality areas.
Obtain and communicate current information regarding regulatory requirements while demonstrating job knowledge and proficiency to monitor evaluate and improve the quality efficiency and appropriateness of numerous ongoing clinical trials.
Manage 2 team managers: Regulatory Lead and Quality Lead
Be a subject matter expert in FDA and ICH regulations, as well as State, local and institutional regulations and policies on clinical trials.
Ensure quality and compliance regulations are adhered to.
Primary point of contact for all regulatory and quality questions and how to interpret them.
Ensure optimization of resourcing for both regulatory and quality teams, advise on optimization of workloads and workflow.
Optimize the quality monitoring process for the region.
Promotes quality and regulatory knowhow and competency throughout the organization.
Responsible for the sccuess of the development, implementation, maintenance, and overall success of the Clinical Trial Program’s regulatory, and quality strategies, objectives, and systems.
Effectively maintains and continuously improves the Quality Management systems.
Provides effective oversight for quality plans and risk management activities and reports.
Leads all QMS internal monitoring activities.
Manages all QMS activities, e.g., deviations, non-conformances, quarantine materials, Corrective and Preventive Actions (CAPAs),
Assures the Organization remains current to and compliant with all applicable standards and regulations.
Owns the regulatory, and quality metrics.
7+ years of professional regulatory and quality experience following policy development, quality assurance, regulatory compliance, strategic planning, directly related healthcare/ clinical trials.
Previous experience running a group of regulatory specialists and/ or quality specialists.
Expert knowledge in FDA regulations and ICH regulations on clinical trials.
5-7 years in quality and regulatory assurance management role/s.
Demonstrated success as a manager who mentors and develops staff through coaching and performance management.
Proven ability to create a high-performance culture of accountability and ownership.
Extensive experience hosting regulatory inspections and interacting with regulators.
Duration: Contract for 6 months
Location: Oakland, CA (hybrid schedule 3+ days in office/ week)
Type: Contract to hire