Manager, Quality Assurance (GVP) (Open to Remote)

MANAGER, PHARMACOVIGILANCE (PV) QUALITY ASSURANCE (Open to Remote)

Position Summary:

As a key member of the Quality Assurance function, this individual will serve as a strategic and tactical quality professional in managing compliance related to Good Pharmacovigilance Practice (GVP) as applicable to clinical trial and post-marketing activities. The individual will be critical in providing GVP compliance guidance to Global Blood Therapeutics, Inc. (GBT) Clinical Operations, 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.  Please note that this role will require an 8am – 5pm Pacific Time work schedule to align with the team.

The Manager GVP QA will be responsible for supporting the development and management of quality infrastructure and processes pertaining to drug safety and pharmacovigilance. The candidate will contribute to activities such as inspection readiness, internal audits and global regulatory inspections, assist with strategies for all agreements where safety activities and input is required, and building robust, compliant processes to ensure the company’s success in continued growth and expansion. This position has the potential to be fully remote. Occasional travel may be required for in person meetings and audits and inspections.

Essential Duties and Responsibilities:

• Promote a culture of compliance and quality within GBT
• Ensures the effective functioning of PV quality management system in compliance with global regulatory authority expectations
• Supports investigations into quality issues identified within PV and ensures event analyses, root cause analysis, corrective, and preventive actions (CAPA) and effectiveness checks are thoroughly documented
• Supports Change Management
• Contribute to due diligence and/or pre-qualification activities of vendors needed to support pharmacovigilance activities
• Support internal and external audits and inspection activities
• Review and analyze audit, inspection and CAPA data to identify compliance trends and areas of exposure
• Supports the creation of systems and processes, Standard Operating Procedures (SOPs) and Work Instructions (WI)
• Supports the development and implementation of PV Key Performance Indicators (KPI's) used to determine the effectiveness of the overall pharmacovigilance system
• Represents PV QA as a subject matter expert during audits and inspections
• Review new regulatory requirements and perform impact analysis to existing processes

Qualifications:

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in Pharmacovigilance
• 5+ years in the pharmaceutical industry setting; 2+ years’ experience working in Pharmacovigilance, clinical and post-marketing, specifically within quality and compliance
• Knowledge of FDA, EMA, and ICH regulations and guidelines
• Excellent interpersonal, communication, analytical, and organizational skills
• 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
• Strong computer skills desirable, particularly Power Point preparations and / or Smartsheets
• Knowledge of safety databases
• 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 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.