Manager / Senior Manager, Clinical Quality Assurance 10/8/2017

Samumed San Diego, CA

Company
Samumed
Location
San Diego, CA
AJE Ref #
579710251
Job Classification
Full Time
Job Type
Regular
Company Ref #
375090
Experience
Entry Level (0 - 2 years)

JOB DESCRIPTION

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About

Samumed is a pharmaceutical platform company based in San Diego, California, focused on advancing regenerative medicine and oncology applications through research and innovation (www.samumed.com). Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the company to develop small molecule drugs that have the potential to address numerous degenerative conditions as well as many forms of cancer. Samumed is currently conducting clinical trials for multiple disease areas, including oncology, osteoarthritis, androgenetic alopecia, tendinopathy, degenerative disc disease, and idiopathic pulmonary fibrosis, and it has a broad pipeline targeting areas of significant unmet medical need.

Job Description and Responsibilities:

Samumed is looking for an experienced and talented Manager/Senior Manager, Clinical Quality Assurance to join its Quality Assurance team. This position will be responsible for establishing and managing processes to control the quality of clinical studies conducted by Samumed. Responsibilities include ensuring adherence to the agency regulations, GxP, Industry Guidelines, local regulations, and internal policies and procedures for the conduct of clinical trials. This position works closely with Clinical Development, Data Management, other supporting areas/teams as, well as site investigators and coordinators to ensure study compliance. This position will be based in Samumed s San Diego office. Specific responsibilities of the position include:

Performing routine and non-routine quality assurance audits to include: clinical investigator sites, vendors, process, system, study project and document reviews to assure quality assurance compliance with regard to all internal procedures, as well as regulatory guidelines
Providing GCP/QA oversight and support to internal staff and clinical investigator sites to ensure compliance to SOPs, GCP and other relevant Good Regulated Practice (GXP) requirements
Assisting in the hosting of regulatory (e.g., FDA, EMA, OSHA, DHHS, etc.) inspectors, as necessary
Writing and reviewing Clinical SOPs and other quality documents
Developing and implementing detailed audit plans and schedules
Ensuring the timely and effective follow up of all identified or assigned quality issues
Assisting in preparing investigational sites for regulatory inspections
Keeping up-to-date with relevant guidelines and assist with regularly scheduled internal training
Writing and reviewing procedures and other controlled documents
Participating in the development and delivery of internal training programs