Contract - Specialist, Clinical Quality Assurance (GCP)

CONTRACT - SPECIALIST, CLINICAL QUALITY ASSURANCE (GCP)

Position Summary:

This individual will provide direct support to the Director Clinical Quality Assurance (CQA) in managing compliance related to GCP, pharmacovigilance and other related activities. The individual will provide compliance support to the Global Blood Therapeutic (GBT) Clinical Development (Clinical Operations, Data Management, Biometrics, Safety/PV), overseeing the GCP audit programs and developing, maintaining and continuously improving the GCP Quality System.

Essential Duties and Responsibilities:

• Promote a culture of compliance and quality within GBT
• Support continuous improvement of quality processes and systems that assure compliance of clinical study-related activities conducted by GBT and in collaboration with GBT contract research organizations
• Support preparations for and follow-up of effective audits of investigator sites, essential documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, vendors, and internal processes
• Provide effective oversight of systems cross-functionally in clinical research and development in collaboration with matrix team members (attend internal Study Execution Team Meetings and corresponding external study meetings)
• Ability to identify, evaluate, and communicate risks to Clinical Quality Assurance processes and/or systems with recommendations for resolution
• Support training company staff and external partners in GCP compliance and GBT clinical practices and procedures
• Administer VEEVA Audits and CAPA system. Enters the Annual Internal Audit Schedule and External Audit Schedule. Manages corresponding workflows ensures documentation is maintained per procedures
• Promote collaboration internally and with external partners to ensure all systems, processes, and their outcomes comply with applicable international and national standards, regulations, and guidelines
• Support GBT GCP inspection readiness

Qualifications:

• Bachelor's degree in a scientific field preferred3+ years of experience in Clinical Quality Assurance, Quality Assurance or Clinical Operations Role. Broad knowledge of risk-based quality systems approaches consistent with ICH E-6(R2) for Good Clinical Practice. Experience with all phases of clinical trials
• Knowledge of Good Clinical Practices (FDA and ICH), a solid understanding of 21 CFR Part 11 with respect to clinical systems, including database, eCRF validation procedures, eCTD Quality Assurance, and eTMF requirements
• Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner
• Attention to detail as well as a crisp, clear and concise style in written and oral communications
• Demonstrated ability to work independently and flexibly in a fast-paced, high growth environment
• Experience supporting inspection-readiness activities (FDA, EMA)

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.