Genopis 인력 채용 관련

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유전자 치료제 생산과 FDA 승인을 위해 작년부터 전문 인력을 계속 채용하고 있습니다. 

 

미국 임상 3상 결과에 대한 자신감이 이런곳에서 보여주는 군요...  조만간 좋은 소식을 기대해 봅니다. 

 

회사의 가치는 계속 성장하고 있습니다. 주가의 변동성은 신경 쓰면 쓸수록 스트레스만 많아집니다. 

회사를 믿고 그 회사의 기술력과 향후 상용화시에 시장에 미치는 영향을 고민하시기 바랍니다. 

 

주가가 하락하면 힘들지만 끈기와 인내로 이겨내어야 달콤한 결과를 얻을 수 있을 것입니다. 

 

Manager/Sr Manager Quality Assurance, GCP

Genopis Inc - San Diego, CA 92121

$110,000 - $115,000 a year

 

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Summary

The Manager/Sr. Manager of GcP Quality Assurance evaluates, maintains and enhances Quality Compliance activities to ensure that ViroMed Quality and Compliance Standards and applicable Government Regulations are met, and vendors achieve, maintain and improve the current level of compliance.

Responsibilities

• Facilitates the development, implementation and maintenance of QA systems and SOPs for GCP activities.

• Supports daily and end-to-end compliance aspects of the portfolio of GcP focused vendors in a virtual work environment.

• Works with internal GcP customers and develop and execute strategic audit plans.

• Coordinates, develops, maintains and/or provides GcP training.

• Maintains relevant knowledge of both local and international auditing and appropriate GcP requirements and developments as they impact ViroMed SOPs and compliance with GcP, and communicate these to QA management, as applicable.

• Provides extensive experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant areas, including applicable GcP auditing.

• Provides expertise in GcP regulations and guidance for FDA and International agencies including ICH guidelines.

• Stays current with industry best practices and regulatory guidance.

• Plans, prepares, performs and reviews audits according to the audit schedule.

• Trending QMS and audit findings

• Reviews clinical deviations and clinical deviation trends.

• Ensures the establishment of an appropriate audit responses and timescale of corrective actions in cooperation with vendors/stakeholders

• Monitors vendor corrective and preventive actions.

• Supports the Internal Audit Program.

• Participates in Inspection Readiness activities including FDA "Mock" inspections, training and support activities.

• Supports Regulatory and Third-Party Inspections.

• Ensures Risk Registrars are prepared and maintained for clinical studies and Drug Program issues.

• Other GcP related tasks, as assigned.

Requirements

Professional Experience/ Qualifications

BA/BS in science or equivalent with at least 5-8 years relevant experience in the Pharmaceutical Industry

• In-depth knowledge of Pharmaceutical regulations: GcP, PV, and Health regulations (ICH, FDA, EU, main local regulations).

• In-depth knowledge of Pharmaceutical Operations

• Thorough experience auditing GcP regulated areas

• Experience in FDA Regulatory Inspection supportㅍ