Director, Clinical Quality Assurance - South San Franicsco, CA | Biospace
Get Our FREE Industry eNewsletter

Director, Clinical Quality Assurance

Global Blood Therapeutics

Apply
Location:
South San Franicsco, CA
Posted Date:
5/18/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

As the leader of GBT’s Clinical QA function, this individual will serve as a strategic and tactical quality professional in managing compliance related to GCPs, pharmacovigilance and other related activities.  The individual will be a critical team member who designs and implements risk-based GCP audit programs and compliance oversight.

Roles/Responsibilities:

•   Establish and lead GBT’s Clinical QA function while promoting a culture of quality within GBT.
•   Planning, coordination, control, and continuous improvement of processes and systems to assure the quality of clinical studies conducted by GBT.
•   Provides effective oversight of systems within Clinical QA and all cross-functional organizations involved in clinical research activities in collaboration with matrix team members and CRO/vendor partners, as appropriate.
•   Development and implementation of GCP-related quality systems.  Oversee audit plans and activities.  Actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct and reporting while championing the highest standards of compliance.
•   Training of company staff.
•   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.
•   Experience in conducting effective audits of investigator sites, documents, Trial Master Files, vendors, and internal processes.

Requirements

•   Bachelor’s degree required; advanced degree in a scientific field preferred.
•   >10 years of experience in clinical Quality Assurance.  Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for Good Clinical Practice.  Experience with all phases of clinical trials.
•   Strong knowledge of Good Clinical Practices (FDA and ICH), a good understanding of 21CFR Part 11 with respect to clinical processes and systems, including database and eCRF validation procedures, eCTD Quality Assurance, and the 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 leading inspection-readiness activities resulting in successful FDA inspection.
•   Ability to travel both domestic and internationally, as needed.
Drive, Desire, Motivation
•   Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
•   Comfortable executing on multiple projects independently.

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
•   Excitement about the vision and mission of GBT
•   Integrity
•   Values-based leadership
•   Flexibility