Job details
Job type full-time
Full job description
Job description
We are seeking a highly motivated individual for the role of specialist ii, good pharmacovigilance practice (gvp) quality at kite pharmaThis is a hands-on role where you will perform quality assurance activities to ensure that the company’s pharmacovigilance activities are conducted in accordance with gvp guidelines, applicable regulations and company policies and procedures.
Job responsibilities:
Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
Perform internal and external pharmacovigilance audits (internal, affiliate, third party, vendor, systems) and compliance assessments including risk evaluation & mitigation strategies (rems) audits to ensure compliance with gvp guidelines, applicable regulations and company policies and procedures
Supports the end to end processes related to the planning, conduct and reporting of gvp and rems audits
Supports qa personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews
Writes and/or implements changes to controlled documents (e.g., sops, specifications, methods, etc.) as needed to ensure defined quality objectives are met
Implements and maintains programs and processes to ensure high quality products and compliance with current good pharmacovigilance practices (gvps)
Supports the development, review, and revision of audit plans and tools, sops, guidelines, and other documents
Support effectiveness checks and capas
Assists with inspection readiness activities for regulatory authority inspections and supports tracking of document requests, responses, and supporting documents during inspection
Assists with preparing, managing, and supporting kite teams during third party audits of kite
Provides basic interpretation and guidance for internal and external customers on gvp related regulations / guidelines (fda, ich, eu, etc.) and company procedures and policies
Contributes to the development of continuous quality process improvements
Support the maintenance of quality compliance data and audit metrics
This position may require up to 40% domestic/international travel
Basic qualifications:
Master’s degree with 2+ years of in a gcp/gvp related field or
Bachelor’s degree with 4+ years of gcp/gvp related field related field or
High school diploma with 7+ years of gcp/gvp related field
Preferred qualifications:
Knowledge of global ich gcp, gvp, fda, ema guidelines and regulations
Demonstrates knowledge of qa principles, compliance and audit concepts, industry practices, and standards
Demonstrates audit and investigation skills, and report writing skills
Experience with project management, preparing presentations, and operational excellence
Prior quality management experience
Proficient in microsoft office suite and other applications
Demonstrates interpersonal, verbal and written communication skills
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Note: this position can be based in santa monica, ca or remote-based.
