Senior Specialist, Clinical Quality Assurance (GCP)
As a key member of the Clinical Quality Assurance function, this individual will serve as a tactical quality professional in supporting compliance related to Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP) and other related activities. The individual will be critical in providing compliance support to Global Blood Therapeutics, Inc. (GBT) Clinical Development (Clinical Operations, Data Management, Biometrics, Regulatory Affairs, Clinical Science, Pharmacovigilance and Risk Management, and Medical Affairs). Scope also includes assisting with the GCP/GVP audit programs and developing, maintaining and continuously improving the GCP/GVP Quality Systems. Essential Duties and
Responsibilities:
Promote a culture of compliance and quality within GBT Coordinate and participate in 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 Contribute to effective oversight of systems cross-functionally in clinical research and development in collaboration with matrix team members. Attend Study Execution Team (SET) Meetings as required Administer and support execution of the Clinical Development Compliance Charter Administer and support execution of Clinical Quality Agreements Administer and support execution of Clinical Quality Oversight Plans Participates in the administration of Audits and CAPA system. Ensures adherence to the approved Annual Internal Audit Schedule and External Audit Schedule. Ensures the corresponding workflows and documentation are maintained per procedures May train company staff on GBT clinical practices and procedures, such as initiating internal deviations and CAPA and requirements of vendor owners 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 and administer the planning, execution and follow-up of effective audits of investigator sites, pharmacovigilance vendors, documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, and internal processes Support GBT GCP and GVP inspection readiness
Qualifications:
Bachelor's degree preferred 7
years of experience in Clinical Quality Assurance, Quality Assurance or Clinical Operations Role. Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice. Experience with all phases of clinical trials Knowledge of Good Clinical Practices (FDA and ICH), Pharmacovigilance (FDA and EMA), 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 resulting in successful agency (FDA, EMA) inspections Ability to travel both domestic and internationally, as needed. Expected travel up to 10% 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. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Promote a culture of compliance and quality within GBT Coordinate and participate in 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 Contribute to effective oversight of systems cross-functionally in clinical research and development in collaboration with matrix team members. Attend Study Execution Team (SET) Meetings as required Administer and support execution of the Clinical Development Compliance Charter Administer and support execution of Clinical Quality Agreements Administer and support execution of Clinical Quality Oversight Plans Participates in the administration of Audits and CAPA system. Ensures adherence to the approved Annual Internal Audit Schedule and External Audit Schedule. Ensures the corresponding workflows and documentation are maintained per procedures May train company staff on GBT clinical practices and procedures, such as initiating internal deviations and CAPA and requirements of vendor owners 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 and administer the planning, execution and follow-up of effective audits of investigator sites, pharmacovigilance vendors, documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, and internal processes Support GBT GCP and GVP inspection readiness
Qualifications:
Bachelor's degree preferred 7
years of experience in Clinical Quality Assurance, Quality Assurance or Clinical Operations Role. Broad knowledge of risk-based quality systems approaches consistent with ICH E6 for Good Clinical Practice. Experience with all phases of clinical trials Knowledge of Good Clinical Practices (FDA and ICH), Pharmacovigilance (FDA and EMA), 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 resulting in successful agency (FDA, EMA) inspections Ability to travel both domestic and internationally, as needed. Expected travel up to 10% 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. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$80K -- $100K
Minimum Qualification
Quality AssuranceEstimated Salary: $20 to $28 per hour based on qualifications.
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