Clinical Trials – Sr. Regulatory and Quality Manager

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.

Responsibilities:

• 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.

Required Skillset:

• 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