HireDiversity

Fremont, CA, US

MANAGER, BIORESEARCH QA-4857121205

Description

Cordis Corporation, a member of Johnson & Johnson's Family of Companies, is looking for a Manager - Bioresearch Monitoring QA. This position can be based in Fremont,CA.

Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products for circulatory disease management.

Over the last 50 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis a strong developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.

The Manager - Bioresearch Monitoring QA shall be responsible for the quality assurance oversight of clinical and pre-clinical studies conducted in support of regulatory submissions for Medical Device products. This is accomplished through the independent audit conduct and issuance of audit reports and recommendation of corrective action while continually keeping Management informed of compliance status. The Manager, Bioresearch Monitoring QA is also responsible for the readiness of investigational sites for FDA inspection. Additionally, the Manager, Bioresearch Monitoring QA reviews and recommends compliance related policies/procedures and evaluates impending regulations, guidelines and industry standards and their impact on the clinical/pre-clinical trials and GLP supported activities and the company.

The Manager will be responsible for managing SOPs, Forms, Guidelines and Templates; performing ICH, GCP, GLP, ISO, MDD, and associated CFR training as needed. This person also plans and conducts audits of clinical/pre-clinical studies, GLP/Analytical support, CROs, external and internal laboratories, internal processes, databases and study reports, as necessary. The Manager provides assurance that clinical/pre-clinical studies and GLP/Analytical support are conducted and that data generated and reported are in compliance with all protocols and appropriate regulatory requirements through document reviews and audits. This person creates, maintains and issues Master Schedules of all trials by test articles in GCP/GLP appropriate as per regulations. The Manager conducts scheduled and ad-hoc audits during the length of several on-going studies to evaluate internal processes related to conduct and reporting of clinical/pre-clinical studies to assure compliance with study protocols, SOPs, GLPs, GCPs and all appropriate regulatory requirements; conducts in-process audits of animal related preclinical procedures and studies; issues audit reports, provides guidance on corrective action plans and may conduct follow up to audits and corrective actions. This person will maintain tracking and trending of audit reports, corrective action activities, etc. in order to maintain visibility of possible negative trends that may be escalated in management reviews; provides timely written reports to inform management of regulatory status based on audits of CROs, investigator sites, studies, analytical data/support and internal audits of processes; and clearly communicates risks to senior management. This person is responsible for managing QA Standard Operating procedures and training applicable departments and internal business partners of said procedures. SOPs will be controlled and maintained in the Franchise document management system.

The Manager is responsible for assuring that all clinical/pre-clinical studies sponsored by Cordis are conducted to the highest standards thereby protecting the business; providing assurance that all internal systems, processes and procedures are set up, maintained and followed (Clinical, preclinical, analytical, etc.); functioning as the Quality Assurance Unit (QAU) for clinical/pre-clinical studies; the development, maintenance and issuance of Global Quality Assurance SOPs; and assisting Compliance staff in hosting and supporting 3rd party compliance audits.

This person will be a valued, proactive and sought-after business partner while continually striving to find appropriate method/venue to support the BU; support External Audits (agencies and notified bodies) as required by the BU and assists in preparing clinical/pre-clinical study areas for FDA inspections; provides QAU support and responses in support of any FDA 483s and partnering with the BU timelines; ensures the business is in a constant state of readiness for ISO, FDA and outside regulatory audits; attends appropriate outside meetings and courses to maintain competency and awareness in regulatory requirements, GCP/GLP/GMP training, worldwide quality activities, and the medical device industry at large; and facilitates the exchange of best practices through external benchmarking.

Qualifications


A Bachelor's degree in a scientific or technical field is required. A BSN or RN is also acceptable. A minimum of 8 years experience in the Medical Device / Biopharmaceutical industry is required. A minimum of three years experience auditing clinical sites and CROs, clinical laboratories, analytical and R&D laboratories, animal facilities, clinical study reports, and/or internal systems is preferred. Previous clinical monitoring experience is preferred. Working knowledge of FDA regulations in the areas of GCP and GLP, ISO and ICH international standards guidance documents is required. PC skills to include Word, Excel, Outlook, etc are required. This position requires strong written and verbal communication skills, the ability to clearly articulate procedures and regulations to a variety of audiences, strong organizational and time management skills, and the ability to work both independently and in teams. This position will be located in Fremont,CA and requires up to 30% domestic and international travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-California-Fremont
Organization: Cordis Corporation (6017)