Job description

KindredBio is a veterinary biopharmaceutical company dedicated to saving and improving the lives of companion animals. KindredBio is establishing a GMP Biologics program. The person in this QA role is responsible for the Quality oversight of the GMP Biologics manufacturing at KindredBio. This includes both oversight of the internal manufacturing as well as the external manufacturing in the Biologics area.

Responsibilities include, but are not limited to:

  • Develops quality assurance goals and systems, including prioritization, resourcing, and selection of QA staff for the Biologics
  • Provides Quality GMP oversight to the KindredBio Biologics manufacturing facility and
  • Available for guidance and answer questions by providing ‘on the floor’ support during all aspects of
  • Work in a team setting to develop and approve batch
  • Provide batch release support and approval for all batches
  • Provide oversight of the Laboratories supporting the Biologics manufacturing
  • Manages the Quality System, Quality Control and Quality Assurance functions at Kindred Bio, including the program to maintain calibrated and validated equipment, and the GMP systems to make Drug Substance and Drug Product, both internally and
  • Support the qualification of the Biologics equipment and facilities and systems for the Biologics
  • Assist in the generation of Annual Product
  • Review documents such as protocols, reports or any other controlled
  • Assures those suppliers/contractor/service providers associated with Biologics manufacturing are operating in compliance GMPs, pertinent regulations and established industry
  • Prepare, coordinate and participate in regulatory
  • Support the SOP management system as related to Biologics GMP manufacturing, and contribute to the preparation and review of the
  • Directly participates in internal audits or
  • Works within a team to conduct the regular, scheduled, senior management review of the adequacy and effectiveness of the Quality Management
  • Conducts regular GMP audits of the internal and external GMP production facilities to assure the sites are meeting the appropriate regulatory
  • Works within a team to implement and maintains an efficient, cost‐effective quality system that emphasizes procedures that are appropriate for the size and scope of the company.

Qualifications/Skills required:

  • Bachelor’s Degree in a scientific (Biological) discipline; Master’s/Ph.D. degree preferred
  • Knowledge of molecular biology techniques such as DNA/RNA isolation and analysis or DNA sequencing
  • At least 7 years of experience in a regulated Biologics pharmaceutical manufacturing environment
  • A comprehensive understanding of GMP, FDA, and ICH/VICH regulations for Biologics manufacturing.
  • Familiar with a variety of the field’s concepts, practices, and procedures
  • Relies on extensive experience and judgment to plan and accomplish goals
  • Strong interpersonal, teamwork, organizational and workload planning skills are required
  • A wide degree of creativity and latitude is expected
  • Performs a variety of tasks and leads and directs the work of others
  • Travel up to 15%

Department

Quality Assurance

Status

Full-time

Reports to

CSO and EVP of Regulatory Affairs and Quality

Location

Burlingame, CA