Government, Regulatory and Code, Pharmaceutical, Quality, Quality Engineering
4 Year Degree
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.
Additional Salary Information: We offer a comprehensive benefits package which includes 100% employer paid premiums for medical, dental, vision, 403(b) retirement contribution, life & LTD insurance, as well as generous paid time off and MUCH more!
Internal Number: DQC.0618
About Cancer Research And Biostatistics (CRAB)
CRAB’s approach to preventing and curing cancer is to collaborate with investigators to design, implement, and execute clinical trials such that reliable and replicable results are obtained. Clinical trials are extremely expensive and will guide new therapeutics, prevention programs and standards of care. Thus we contribute our expertise from the design of the study and protocol development through to the final analysis and publication of results.
Our highly trained cancer research specialists, together with collaborators, leverage CRAB’s proprietary customizable database and electronic data capture system, to provide seamless data collection, query tracking, and resolution so that analyses follow immediately upon study completion.
CRAB KNOWS CANCER
- CRAB is a 501(c)(3) non-profit organization, founded in 1997 by internationally renowned biostatistician John Crowley, Ph.D. to perform unique and critical roles in the battle against cancer.
- Research teams at CRAB, under the direction of President and CEO Antje Hoering, Ph.D., lead the development of statistical methods and technologies to optimize cancer research and the clinical trial process.
- SWOG continues to be our ...primary partner and collaborator, but CRAB’s clinical trial services extend to other consortia, research institutes and pharmaceutical companies.
- We possess expertise and provide data in cancer staging, historical controls, high dimensional genomic correlatives and targeted designs and therapies.
- CRAB is mission driven - our goal is to prevent and cure cancer. We are committed to assuring the highest research quality and integrity so that patients on our trials and others who follow them will benefit from the knowledge gained.
- We have the integrity and diversity of expertise needed to successfully advance clinical trials of promising new therapies.
- CRAB has pioneered the development of statistical methods and technologies to optimize cancer research.