Manager of Quality Assurance

Manages the operation and compliance of the critical quality systems of lot release, change control (documents, systems, equipment, etc.), documentation, internal and external audits, vendor qualification, deviations, CAPA, and complaints. Responsible for assuring that the quality levels of raw materials, finished products, and plant documentation meet established quality standards. This position supervises 5 employees.

Principal Accountabilities:
•Manage the operation and compliance of the critical quality systems of finished product lot release, change control (documents, systems, equipment, etc.), documentation, internal and external audits, vendor qualification, deviations, CAPA, and complaints.
•Evaluate and redesign quality and plant systems to meet operational and regulatory compliance requirements for a commercial manufacturing site.
•Manage and develop QA staff
•Assist in preparing the facility for PAI inspection, including auditing, system redesign and implementation, training of site personnel, and the general identification of potential GMP improvement opportunities.
•Supports other QA/QC/Validation/Training functions as necessary, provides GCP support to Corporate
REQUIREMENTS
•BS in science or related discipline with knowledge of biochemical and biological processing
•7+ years broad spectrum experience in the commercial pharmaceutical quality area, preferably one involving aseptic processing and LVPs
•5+ years people management experience in a pharmaceutical/biologic compliance related area

Specific Technical/Job-Related Skills:
•A thorough understanding of the quality requirements for compliance with cGMP, FDA, (CBER and CDER), ICH, and USP expectations; and an understanding of how these requirements are typically fulfilled by the pharmaceutical/biologic manufacturing industry.
•Supervisory and leadership skills necessary to manage and develop QA staff to a high level of performance.
•Interpersonal skills required for monitoring the performance of other departments in meeting compliance objectives; and for interactions with vendors, service providers, and regulatory agencies
•Strong written communication skills for SOPs, reports to management, and other written correspondence
•Strong oral communication skills for presentations involving quality issues to teams, management, and regulatory agencies
•Analytical thinking, problem solving, results oriented, customer focused