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Miles
Km80.5

Sr. Director of Quality Control

Lab Support, A Division Of On Assignment

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Location: Irvine, CA, CA Posted Date: 5/2/2013 Position Type: Full time Job Code: CM 00001 Required Education: High school or equivalent

Description

Large International Manufacturer of Pharmaceuticals is seeking a Sr. Director of Quality Control.

The ideal candidate will have 15 years of experience as Sr. Director/Director of Quality Control within the Pharmaceutical Industry. This company offers excellent benefits, perks, and competitive salary.

Summary
Position will report into the site head of QA, but will play a large role within the organization. The candidate will have extensive experience with method transfers.

Duties and responsibilities
•   Establish and implement site quality and regulatory policies to ensure compliance with federal, state, and international regulations.
•   Develop current and long range strategic plans for Quality, Validation and Training functions to be consistent with overall business objectives, regulatory requirements and improvements in technology.
•   Interface directly with regulatory agencies and contract customers to address product quality and regulatory issues.
•   Key Quality representative of GSPI to FDA, EMEA, MCA and regulatory agencies.
•   Provide leadership and direction in order to direct activities related to validation of manufacturing processes, equipment and facilities.
•   Development of protocols, analytical validation, and final approval of validation activities.
•   Anticipate and plan for resource needs, and determine appropriate staffing & budget needs to assure company goals are met.
•   Establish goals and priorities for the Quality organization to be in line with site and corporate objectives.
•   Provide a Quality risk assessment to projects and processes to assure we operate within a compliant environment.
•   Interface with department heads to implement and maintain site strategic plans, company policies and regulatory requirements.

Requirements

•   Education Required: Bachelor Degree in Science or related field
•   Experience Required: 15-20 years pharmaceutical and manufacturing experience. Thorough knowledge of cGMPs, GCPs, and FDA regulations related to applications and general pharmaceutical manufacturing practices.
•   Experience Preferred: DEA Regulations and MS or PhD in Science or related field    
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