Quality Assurance Manager

Management Pathways has been retained to assist our client the search for a Quality Assurance Manager. This is a unique opportunity with an established, profitable and growing $500 million pharmaceutical company based globally in France, with U.S. headquarters outside Philadelphia in Newtown Square, PA. Our client is the world leader in a specialty OTC pharmaceutical niche, and seeks a QA Manager to plan and develop programs to ensure compliance with company and regulatory standards. This individual will supervise two QA Specialists located at East Coast (Pennsylvania) and West Coast (California) branch locations, and manage quality initiatives in conjunction with international QA counterparts in Europe and worldwide. The scope of this role includes:

-SOP development;
-Validation of processes, equipment, computer systems and facilities;
-Auditing of BOIRON and vendor sites;
-Employee training program development and management;
-Equipment calibration;
-Complaint investigation;
-Liaison to contracted analytical laboratories;
-In conjunction with Regulatory Affairs, oversees/manages inspections by regulator agencies;
REQUIREMENTS
The ideal candidate will possess both the technical knowledge and management skills necessary to lead and develop a Quality Assurance program in a dynamic business atmosphere. This individual will have a strong "generalist" background in a related pharmaceutical or laboratory environment, and the ability to guide QA efforts across multiple areas of operation. An ability to communicate effectively and persuasively is important in this role, including frequent cross-cultural interaction. The QA Manager will be proactive, diplomatic, and flexible, and provide independent leadership to a variety of projects, including longer range initiatives.

Requirements:

-BS/BA degree in a life science area;
-A minimum of five (5) years experience in the pharmaceutical industry or related cGMP environment is required;
-A minimum of two (2) years supervisory experience is required;
-Strong analytical and problem-solving skills;
-An ability to work independently to manage activities and tasks;
-Positive communication and interpersonal skills;
-Highly organized with strong follow through and time management;