Senior Specialist - GMP Quality

Location
San Francisco, CA, United States
Posted
Mar 31, 2021
Ref
1056
Hotbed
Biotech Bay
Required Education
Other
Position Type
Full time
SENIOR SPECIALIST - GMP QUALITY

Position Summary:

The primary responsibility of this position is to provide input and oversight to ensure all operations meet or exceed cGMP regulations. The Specialist/Senior Specialist, Quality Assurance (QA) will provide ensuring a high level of quality and compliance of the GBT Manufacturing operations. The position will focus on partnering with stakeholders to review and approve deviations, out-of-specification (OOS) investigations, standard operating procedures (SOPs), and lead root cause analysis discussions. This position will also support quality key metrics tracking, reporting and analysis.

This role reports to the Sr. Director of Quality Operations.

Essential Duties and Responsibilities:

  • Primary contact for all Open quality Records from opening to closure
  • Support the closure and content of change control at GBT
  • Interface with Quality and Technical Operations to drive timely completion of review cycles, approvals and investigations
  • Support QA Operation process improvement programs
  • Perform Quality records review including data integrity oversight in a cGMP manufacturing environment
  • Support operational staff on disposition of GBT products
  • Develop QA operation data dashboards metrics, QMR, and to facilitate process improvements
  • Create and manage the GMP Quality Agreements (logistics) program at GBT
  • Manage the APQR, program at GBT
  • Support QMS EU Launch, transition of GMP documents to EDMS, and Vendor Notifications
  • Support Vendor Assessments, Ops Major Deviation/CAPA Review, and PQRB
  • Interface with Training Specialist to address training needs for QA Operations
  • Perform Source data verification
  • Support QA operations that ensures inspection readiness
  • Support regulatory inspections as appropriate
  • Support business contracts and Quality agreements


Qualifications:

  • Bachelor's degree in a scientific-related field or equivalent experience and 8-10 years' experience in the life sciences industry
  • High level of professionalism and collaboration in team settings
  • Expertise in Quality supporting quality and compliance with respect to deviations, investigations and process change controls
  • Strong problem-solving, decision-making skills, interpersonal skills and ability to work in a team environment
  • Strong understanding of FDA, EMA, local regulations and guidelines, Good Manufacturing Practices, ICH guidelines, and industry best practices Quality Assurance experience using risk-based approaches
  • Demonstrated experience with investigations into manufacturing deviations and determination of product impact potential, root cause, and corrective actions Excellent technical writing, verbal communication and time management skills


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.