Senior Manager, Quality Systems (GXP)

Location
San Francisco, CA, United States
Posted
May 30, 2021
Ref
1057
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SENIOR MANAGER, QUALITY SYSTEMS (GXP) - Remote Position

Position Summary:

As a key member of the Quality Systems team, this individual will serve as a strategic and tactical quality professional managing systems and compliance to support GxP operations and Quality functions at GBT. The individual will serve a critical, highly influential role in providing compliance guidance to Global Blood Therapeutics, Inc. (GBT) and developing and implementing GxP Quality Systems such as the Exception Management Program, Vendor Management Program and/or GxP Risk Management Program and other Quality Systems. This individual will be a processes owner, ensuring reliable stakeholder support/guidance and communication, robust procedures, tools to execute the process, and adequate training curricula and metrics to drive improvement. This individual will be a key member of the Quality Organization to drive maturity, compliance, and ease of use of the Quality Management System.

Essential Duties and Responsibilities:

  • Promote a culture of compliance and quality within GBT
  • Improve, maintain, and implement and oversee GxP quality systems
  • Serve as a champion, advocate and coach to GBT as a Quality Systems process owner
  • 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
  • Serves as Process Owner of several Quality systems processes to support GBT colleagues in the adoption, execution, adherence to process requirements
  • 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, processes, and their outcomes comply with 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
  • 7+ years of experience in Quality Assurance or Quality Operations Role in the pharmaceutical/biotech industry
  • Broad knowledge of risk-based quality systems approaches including Product Complaints, Deviations, CAPA, Risk Management, Vendor Management, Change Control, and Audits
  • Knowledge of GxPs (FDA, EMA and ICH), a solid understanding of 21 CFR Part 11 / Annex 11
  • 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
  • Demonstrated capability as an effective indirect leader within an organization
  • 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.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

#LI-TB1