Plan and coordinate all aspects of quality assurance activities for two pharmaceutical warehouse operations, accommodate requests for quality support from site group and communicate policies and procedures in support of the business. Act as the subject matter expert regarding quality and governmental regulations for site group. Act as the primary quality assurance customer contact.
Manage (including planning) the audit process to monitor the quality system and compliance with regulatory and customer requirements.
Coordinate ISO registration and other compliance activities.
Assist Director, QA/RA to develop and analyse information and product specifications to determine standards and policies in the following areas: FDA regulations, DEA regulations, other product regulatory requirements.
Establish, maintain and continually improve the overall quality system.
Provide leadership on key regulatory, customer and 3rd part audits.
Assist Director of QA to develop and implement quality-related training programs for management, field operations and QA associates.
Track quality assurance metrics for the organization.
Assist Director of QA to develop, distribute and maintain regular management reports.
Work in concert with Continuous Improvement team to focus/direct CIP activities/workshops.
Act as primary customer interface for significant QA related issues/initiatives; coordinate participation of other members of the account team as appropriate.
Act as primary advisor to the operations management team on QA issues/initiatives (e.g. problem solving, identification and escalation of significant QA issues).
Hire and manage staff
Bachelors Degree in Business or related field (MBA preferred)
Major participation in a successful ISO registration of a relatively large and complex organization
At least 5 years of Management/supervision with at least two year supervising or managing a quality system and organization
Certified Quality Engineer, Quality Auditor, Quality Manager, Six-Sigma, RAC , etc
Project Management experience
Effective management of direct reports