Senior Manager, Quality Systems (GXP) (Open to Remote)
Global Blood Therapeutics, Inc. (GBT) Quality Systems Team (QST) is a group of highly motivated, knowledgeable, collaborative creative thinkers responsible for the design, implementation, and continuous improvement of GBT's GxP Quality Systems globally. The QST is a service-oriented function dedicated to enabling effective, efficient, fit-for-purpose Quality Systems to support GMP, GDP, GCP, GVP Operations and Quality functions. As a key member of the Quality Systems team, this individual will serve as a strategic and tactical quality professional managing systems and compliance for GBT. This role is critical in providing compliance guidance to Global Blood Therapeutics, Inc. (GBT) pertaining to GBT's Quality Management System. This individual will be responsible for the ownership of GBT's Product Quality Complaints Program and for administering GBT's Quality Risk Management program. As process owner of these areas, this individual will responsible for ensuring reliable stakeholder support/guidance and communication, robust procedures, and tools to execute the process, adequate training curricula and metrics to drive improvement of the systems. This individual will be a key member of the Quality Organization to drive maturity, compliance, and ease of use of the Quality Management System, especially relating to Product Quality Complaints and Quality Risk Management. Essential Duties and
Responsibilities:
Promote a culture of compliance and quality within GBT Improve, maintain, implement, and oversee GxP quality systems globally Serve as a Quality Systems process owner for GBT's Product Quality Complaints and Quality Risk Management- expert, champion, advocate and coach - for GBT and support GBT colleagues in the adoption, execution, adherence to process requirements Plan and coordinate continuous improvement of quality processes and systems that assure compliance of GxP activities conducted by GBT and GBT vendors Provide effective oversight and leadership of systems cross-functionally across GxP Ensure execution of Annual Quality Plan elements Identify, evaluate, and communicate risks associated with GxP Systems Train company staff and external partners in GxP compliance and GBT processes and procedures Promote collaboration internally and with external partners to ensure all systems and processes support the needs of GBT and applicable international and national standards, regulations, and guidelines Support GBT GXP inspection readiness
Qualifications:
Bachelor's degree required; advanced degree in a scientific field preferred 6
years of experience in Quality Assurance or Quality Operations Role. Broad knowledge of risk-based quality systems approaches including Product Complaints, Deviations, CAPA, Risk Management Knowledge of GxPs (FDA, EMA and ICH) Expertise in Vendor Management including qualification, oversight, metrics across GMP/GDP, GCP, GVP, GLP Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner Initiative and self-motivated to drive process/programs forward with focus on innovation and stakeholder support 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, openness, and creative approach to problem solving Consistently operates with a very high level of 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 may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time 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 ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Promote a culture of compliance and quality within GBT Improve, maintain, implement, and oversee GxP quality systems globally Serve as a Quality Systems process owner for GBT's Product Quality Complaints and Quality Risk Management- expert, champion, advocate and coach - for GBT and support GBT colleagues in the adoption, execution, adherence to process requirements Plan and coordinate continuous improvement of quality processes and systems that assure compliance of GxP activities conducted by GBT and GBT vendors Provide effective oversight and leadership of systems cross-functionally across GxP Ensure execution of Annual Quality Plan elements Identify, evaluate, and communicate risks associated with GxP Systems Train company staff and external partners in GxP compliance and GBT processes and procedures Promote collaboration internally and with external partners to ensure all systems and processes support the needs of GBT and applicable international and national standards, regulations, and guidelines Support GBT GXP inspection readiness
Qualifications:
Bachelor's degree required; advanced degree in a scientific field preferred 6
years of experience in Quality Assurance or Quality Operations Role. Broad knowledge of risk-based quality systems approaches including Product Complaints, Deviations, CAPA, Risk Management Knowledge of GxPs (FDA, EMA and ICH) Expertise in Vendor Management including qualification, oversight, metrics across GMP/GDP, GCP, GVP, GLP Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner Initiative and self-motivated to drive process/programs forward with focus on innovation and stakeholder support 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, openness, and creative approach to problem solving Consistently operates with a very high level of 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 may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time 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 ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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