Associate Director/Director, Quality Systems - San Carlos, CA | Biospace
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Associate Director/Director, Quality Systems

Iovance Biotherapeutics, Inc.

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Location:
San Carlos, CA
Posted Date:
9/1/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Director, Quality,

Job Description


Overview

The Associate Director/Director, Quality Systems will be responsible for the improvement, design, development, implementation and maintenance of the GxP Quality Management System (QMS) processes. This includes, but is not limited to, Change Control, Deviation and other Non-Conformances, CAPA, Supplier Management, and Risk Management. The Associate Director/Director, Quality Systems will address gaps associated with the current Quality System processes as part of preparations for current Phase 2 and future Phase 3 clinical operations.

Specific Responsibilities

•   Lead the development, continuous improvement and implementation of Quality Systems.
•   Improve and establish standard operating procedures for efficient and compliant management of GxP QMS processes.
•   Establish and track quality metrics for QMS processes and present improvement opportunities at Management Review meetings.
•   Implement risk management based approaches.
•   Conduct domestic and international Quality System audits (e.g., CMO Qualification, Assessment, For Cause, and/or Periodic audits) to ensure that the sites operate in compliance with EU/FDA/ICH and other regulatory bodies as may be required and remain GMP inspection ready at all times.
•   Interface with FDA/EU and other regulatory agencies, vendors and consultants.
•   Represent Quality on cross-functional teams to complete projects, address quality issues and implement quality system improvements.
•   Identify compliance gaps and lead focused teams to resolve compliance issues. Provide written compliance assessments to management on request, and interpret global regulations and apply to a multi-product, multi-modality environment.
•   Develop or review, Operating Procedures (SOPs) required for supporting system change/enhancement to ensure compliance with Good Manufacturing Practices (GMPs) requirements.
•   Establish and maintain policies and procedures to ensure compliance with local, state and federal environmental regulations and standards including compliance with all Food & Drug Administration (FDA) and all other applicable global regulatory requirements.
•   Establish and oversee internal quality systems and policies throughout the company.
•   Responsible for the co-ordination and preparation of activities related to regulatory agency inspections at company facilities, CMOs, vendors and investigator study sites.
•   Prepare GXP quality metrics; analyze data relating to process validations, process controls, and continuous process improvement efforts; coordinate the necessary quality adjustments.

Requirements


Education and Qualifications

•   BA/BS degree in scientific or engineering discipline
•   Accredited quality auditor is desirable
•   10 years of biopharmaceutical industry experience
•   Direct experience with managing key Quality Management System processes (e.g., Change Management, Supplier Management, Deviations/CAPA, and Management Review)
•   In-depth understanding of current global regulatory expectations
•   Experience in preparing for and participating in regulatory inspections to ensure successful outcomes
•   Demonstrated ability to collaborate and influence across organization to gain support and commitment for team goals; effective management of groups of professionals to achieve desired results
•   Strong professional interpersonal and communications skills, both verbal and written to provide clear direction for the business, vendors, internal stakeholders
•   Ability to meet deadlines and multi-task efficiently
•   Must be comfortable in a fast-paced environment with minimal direction and changing priorities
•   Experience identifying changes, driving improvements and streamlining processes required
•   Proficient with the Microsoft Office Suite, Word, Excel, PowerPoint and Project