Senior Specialist, Quality Systems (GXP)

Location
San Francisco, CA, United States
Posted
Apr 22, 2021
Ref
1082
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SENIOR SPECIALIST, QUALITY SYSTEMS (GXP)

Position Summary:

As a key member of the Quality Systems team, this individual will support GxP operations and Quality functions at GBT. The individual will serve a critical role in assisting with implementation and execution of GxP Quality System processes such as audits, Training, Deviations, CAPA, Change Control, Complaints, metrics reporting and others. This individual will help to ensure stakeholder support, guidance, and communication; robust procedures and documentation; and tools to support execution of the QMS. This individual will be a key member of the Quality Organization to drive maturity and compliance of the GBT Quality Management System.

Essential Duties and Responsibilities:

  • Promote a culture of compliance and quality within GBT
  • Serve as Quality Systems champion, advocate and coach for GBT
  • Coordinate continuous improvement of quality processes and systems that assure compliance of GxP activities conducted by GBT and GBT vendors
  • Supports execution of Annual Quality Plan elements
  • Identify and communicate risks associated with GxP Systems
  • Train and provide on-going support for GBT staff in GXP compliance and Quality Systems processes and procedures
  • Promote collaboration across GxP 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
  • Attention to detail as well as a crisp, clear and concise style in written and oral communications
  • Strong understanding of risk-based quality systems 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 proactively identify quality issues
  • 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


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.