Senior Manager, Clinical Quality Assurance (GCP) at Global Blood Therapeutics in South San Francisco, CA
As a key member of the Clinical Quality Assurance function, this individual will serve as a strategic and tactical quality professional in managing compliance related to GCP, pharmacovigilance and other related activities. The individual will be critical in providing compliance guidance to Global Blood Therapeutics, Inc. (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. Please note standard work hours are 8am - 5pm Pacific Time. Essential Duties and
Responsibilities:
Promote a culture of compliance and quality within GBT Plan and coordinate 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 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) Oversees 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. Actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct while championing the highest standards of compliance. Ability to identify, evaluate, and communicate risks to critical trial processes and data with recommendations for resolution Train company staff and external partners in GCP compliance and GBT clinical practices and procedures Improve, maintain, and implement GCP and PV quality systems. 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 Plan and oversee effective audits of documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, and internal processes Provide compliance guidance and oversight of trial-related duties and functions carried out by the GBT's contracted CRO(s) Support GBT GCP and PV inspection readiness
Qualifications:
Bachelor's degree required; advanced degree in a scientific field preferred 7
years of experience in Clinical Quality Assurance, Pharmacovigilance Quality Assurance or Clinical Operations Role. Broad knowledge of risk-based quality systems approaches consistent with ICH E6(R2) 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 Project leadership experience; supervisor experience a plus (including site monitoring) 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 15% 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:
$100K -- $150K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Promote a culture of compliance and quality within GBT Plan and coordinate 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 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) Oversees 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. Actively leverage audit outcomes/trends to achieve sustained improvement in clinical trial conduct while championing the highest standards of compliance. Ability to identify, evaluate, and communicate risks to critical trial processes and data with recommendations for resolution Train company staff and external partners in GCP compliance and GBT clinical practices and procedures Improve, maintain, and implement GCP and PV quality systems. 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 Plan and oversee effective audits of documents (Protocol, IB, Master Template Inform Consent, CSR), Trial Master Files, and internal processes Provide compliance guidance and oversight of trial-related duties and functions carried out by the GBT's contracted CRO(s) Support GBT GCP and PV inspection readiness
Qualifications:
Bachelor's degree required; advanced degree in a scientific field preferred 7
years of experience in Clinical Quality Assurance, Pharmacovigilance Quality Assurance or Clinical Operations Role. Broad knowledge of risk-based quality systems approaches consistent with ICH E6(R2) 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 Project leadership experience; supervisor experience a plus (including site monitoring) 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 15% 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:
$100K -- $150K
Minimum Qualification
Quality Management, Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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