University of Washington School of Public Health
Director of Regulatory Compliance - Cancer Research And Biostatistics (CRAB)
Closing Date: open until filled
Posted: November 6, 2017
Cancer Research And Biostatistics (CRAB) is a non-profit organization whose purpose is to help conquer cancer and other diseases through the application of biostatistical principles and data management methods.
The Director of Regulatory Compliance will lead quality and regulatory affairs functions at CRAB. This position is responsible for managing Quality Systems and Regulatory Compliance activities to ensure compliance with sponsored clinical trials standards and regulations, including 21 CFR Parts 11, 312 and 820. In addition, this position leads CRAB in comprehensive knowledge of FDA, GCP and GDocP regulations and guidelines. This position reports to the Chief Financial Officer.
Primary Duties and Responsibilities:
- Ensures quality management system requirements are effectively established and maintained in accordance with GCP and Human Subject Protection standard regulations
- Leads the development and execution of quality policy, objectives, and strategic plans
- Directs and oversees all Quality Systems and Regulatory Compliance staff and functions in areas including GCP and GDocP regulations, management review, corrective and preventive actions, internal audits, surveillance and complaints
- Serves as primary reviewer for quality assurance and compliance sections of CRAB contracts and agreements. Develops bid estimates and oversight for regulatory project efforts
- Oversees and provides direction in the following areas: document control, internal quality audits, Corrective and Preventive Actions (CAPA), complaint handling, supplier management, trial history record review, employee training, trial history file maintenance, risk management activities, application validation
- Serves as lead contact for inspections by regulatory agencies
- Represents the quality function on project teams, providing quality and regulatory compliance input, feedback, and guidance
- Reviews and approves Application Change Order (ACO) approval to ensure adherence to quality system requirements
- Assesses the impact of changes to regulations on clinical investigations and FDA filings
- Conducts quality assurance reviews of essential clinical project-related documents including protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports
- Develops, plans and leads readiness for inspections and audits at CRAB by GCP and GDocP regulatory authorities, clinical investigator sites, and contract organizations
- Conducts data auditing and review in support of regulatory submissions and periodic safety reports
- Chairs and coordinates quality management review meetings and oversees action items
- Ensures completion of all corrective actions associated with the quality system and ensures that the CAPA process is compliant with regulatory requirements
- Oversees and performs audit processes, including managing audit resources, tracking status of audit findings to closure, and audit record retention
- Assists with the regulatory submissions made to FDA and all other regulatory agencies to obtain clinical approvals and respond to inquiries
- Performs other duties as related to providing quality program direction and to the mission, goals, and values of CRAB
- Bachelor’s degree or equivalent years of experience in regulatory affairs may be substituted for degree
- Comprehensive knowledge of FDA, GCP and GDocP regulations and guidelines
- Minimum ten years of progressively responsible experience in clinical regulatory affairs and clinical quality assurance
- Minimum seven years of experience with quality systems and/or regulatory compliance functions and protocols
- Minimum three years in a management role with direct reports
- In-depth knowledge of 21 Code of Federal Regulation Parts 11, 312 and 820, and experience with Quality Management Systems
- Demonstrated experience identifying areas for improvement and implementing solutions; ensuring compliance with standards, regulations and company procedures; and administering successful programs within appropriate timelines
- Successfully lead and motivate direct reports
- Ability to interact positively with all levels of staff and external contacts
- Proficiency in Microsoft Word, Outlook, Excel and PowerPoint
- Excellent verbal and written communication skills
- Experience with adopting a flexible service oriented approach and proactive with changing needs
- Limited travel will be required
Desired Knowledge, Skills and Abilities:
- Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society of Quality) Certification is preferred
- Experience in conducting training for quality assurance and/or regulatory affairs
- Experience with on-site monitoring
- Expert planning and organization skills
- Strong attention to detail
- Exceptionally team focused and actively contributes to a positive and innovative work environment
- Able to demonstrate the highest ethical standards; promotes trust, respect and integrity
- Spanish language skills a plus
This is a full-time position and is Exempt from state and federal overtime regulations.
Employment authorization is required.
Travel/relocation expenses will not be provided for this position.
CRAB is an Equal Opportunity Employer.
How to Apply:
In your cover letter, describe how your skills and experience match the qualifications for the position.