Quality Management Systems (QMS) 8/19/2016

KHI Los Angeles, CA

Company
KHI
Job Classification
Full Time
Company Ref #
28886428
AJE Ref #
575935404
Location
Los Angeles, CA
Job Type
Regular

JOB DESCRIPTION

APPLY
El Segundo, CA

A leading cell therapy company is hiring. We are a publically traded biopharmaceutical company looking to bring novel medicines harnessing patients' own immune systems to fight disease including cancer. With a phase 3 study fully recruited, we are aiming to file our first BLA Q42017. We are growing rapidly and looking for an analytical or statistically oriented Quality Systems professional to help drive the development and implementation of metric gathering and analytical tools to support risk monitoring.

In this role, the QUALITY SYSTEMS leader will develop and manage the Quality Engineering function in product manufacturing, analytical testing and supplier quality. In addition, the quality systems professional will develop and manage the OVERALL STRATEGY FOR PROCESS, METHOD, AUTOMATION AND FACILITY QUALIFICATION. You will work closely with research and development staff to IMPROVE THE RELIABILITY OF PROCESSES AND METHODS THROUGH PROCESS AND METHOD DEVELOPMENT AND CHARACTERIZATION. Moreover, IMPLEMENT AND SUSTAIN QUALITY AND OPERATIONS SYSTEMS FOR CLINICAL OPERATIONS AND COMMERCIAL LAUNCH OF OUR PRODUCTS. The QMS professional will DEVELOP AND IMPLEMENT RISK MANAGEMENT STRATEGY AND TOOLS. You will work closely with SMEs to create and implement workflows and business processes that align with best practices that ensure right first time.

RESPONSIBILITIES

* Implement and sustain a qualification and validation system.
* Risk based approach to process and method characterization, qualification and validation.
* Work closely with research and development to create full process and method characterization plans and studies/protocols then assist in executing studies and writing summary reports.
* Develop validation master plans based on FDA/ISPE guidance for all processes and methods related to our lead product and follow on products.
* Prepare and write relevant sections of IND and BLA documents.
* IMPLEMENT AND SUSTAIN RISK MANAGEMENT AND STATISTICAL TOOLS.
* DEVELOP AND IMPLEMENT RISK MANAGEMENT TOOLS FOR JUSTIFICATION OF SPECIFICATIONS AND PROCESSES.
* Work closely with research and development to identify areas of risk and strategies to reduce or eliminate those risks.
* DEVELOP AND IMPLEMENT STATISTICAL TOOLS FOR PROCESS, METHOD AND SUPPLIER MONITORING.
* Quality System development and implementation
* Develop the change control system including CAPA.
* Develop and implement product complaint management system for clinical trials and eventual commercial product launch.
* Develop and implement supplier qualification system to fully qualify all component and material suppliers. Assure back up suppliers are in place and resolve reliability and quality issues with suppliers. Develop robust CMO and CRO oversight program.
* Audit, inspection and due diligence support
* Provide technical response and expertise (written and verbal) during audits, inspections and due diligence on quality related topics and systems.
* Provide independent audit support for CMOs, CROs, and critical suppliers.
* Provide leadership and guidance during FDA or other board of health inspections.

REQUIREMENTS

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8+ years in a technical role in quality engineering, manufacturing, analytical testing or engineering.
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Bachelor's Degree in Engineering, Chemistry or biological sciences.
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Experience in medical device or pharmaceutical bio-pharmaceutical field.
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Education or training in cell culture and gene therapy a plus.
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Proficient in MS Word, Excel, Power Point, Visio, Project, statistical software, and other applications.
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Proficient in drafting and completing highly technical documents and presentations.
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Document management systems demonstrated knowledge in areas such as technical document creation, electronic and paper archival and retrieval.
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Ability to communicate and work independently with scientific/technical personnel.
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Ability to work independently with outside companies to complete complex tasks.
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Must be able to travel