Director of Quality Compliance - Cancer Research And Biostatistics (CRAB)
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 Quality Compliance leads quality compliance 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, GDPR regulations and ICH E6 R2 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 staff and functions in areas including FDA and ICH regulations and guidelines, document control, management review, corrective and preventive actions (CAPA), deviations, change control, internal audits, employee training, supplier management, risk management activities, application validation documentation, 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
- Serves as lead contact for inspections by regulatory agencies and sponsor audits
- Develops, reviews, strengthens, and approves all CRAB controlled documents including policies, SOPs, validation documents, change control, deviations and CAPAs
- Provides Quality compliance impact assessments for all change requests
- 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
- Ensures all deviations are investigated, closed, tracked, trended, and checked for effectiveness
- Leads in developing CRAB staff with a set of tools and training to conduct effective root cause analysis
- Reports quality compliance metrics to CRAB officers and provides recommendations for improvements
- 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 with additional 10 years of progressively responsible experience managing quality compliance/assurance functions. Masters’ degree may substitute for two years of experience
- Comprehensive knowledge of FDA, ICH, EMEA regulations and guidelines
- Minimum five years in a quality 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
- Experience conducting training for quality assurance and/or regulatory affairs
- 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 adopting a flexible, proactive, and service-oriented approach
- Travel may be required
Desired Knowledge, Skills and Abilities:
- Certification in regulatory affairs, quality assurance or clinical research; ASQ (American Society for Quality) Certification is preferred
- Experience with on-site monitoring
- Expert planning and organization skills
- Strong attention to detail
- Exceptionally team focused; 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.
In your cover letter, describe how your skills and experience match the qualifications for the position.
To apply, submit resume and cover letter with position number via mail, fax or email to:
Cancer Research And Biostatistics
Attn: Hiring Coordinator
1730 Minor Avenue, Suite 1900
Seattle, WA 98101-1468
Fax: (206) 342-1689