VICE PRESIDENT, GLOBAL QUALITY ASSURANCE, PHARMACEUTICALQUALIFICATIONSTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Operational knowledge of pharmaceutical dosage form manufacturing techniques and processes and quality controls Operational knowledge of pharmaceutical product development and clinical study processes. Operational knowledge of quality assurance and compliance techniques and procedures. Proficiency in implementing quality management procedures, standards, programs and concepts in a global scope. Technical and scientific expertise sufficient to direct day-to-day group activities. Experience in cross-functional team and project management. Ability to develop and implement quality management tools. Ability to organize and manage the work of department employees. Excellent written and oral communication skills with the Company's various internal and external stakeholders. A spirit of integration and analysis. Ability to work under pressure. Quality of judgment and evaluation of situations. Business sense. Ability to adapt to a rapidly changing environment.Salary $180000 to $200000 + benefits JOB SUMMARYMy client is actively recruiting a Vice President of Quality Assurance located in the Greater Chicago area. Responsible for organizing, managing and controlling all quality assurance and quality compliance activities and tasks for the Company and its subsidiaries while respecting the established regulatory requirements and policies of the Company.ESSENTIAL DUTIES AND RESPONSIBILITIESThe primary duties and responsibilities of this position include the following.
Other duties may be assigned. Directs global quality assurance functions for all manufacturing and clinical related activities of the company. Defines globally-coordinated quality assurance and compliance objectives, quality assurance systems, agreements, training programs, and policies for all Company and subsidiaries and develops the necessary plans and actions to meet established objectives. Organizes and manages quality assurance team to meet requirements and objectives of the function. Evaluates site audit findings and responds to these findings with globally-aligned process and procedure improvements that drive quality system efficiency and effectiveness. Provides quality assurance expertise to all operating groups and establishes and participates in cross-functional teams as required. Provides support and assistance to Regulatory and Medical Affairs in preparation of regulatory submissions and reviews. Provides support to answering Regulatory (FDA, TPD, EMEA, etc.) questions/comments during filing review in their quality assurance function. Participates actively in maintaining relationships with regulatory authorities (FDA, TPD, etc.). Ensures appropriate risk assessment with regards to projects/available resources. Manages human resources and provides coaching to the quality assurance team.(Real Staffing Group acts as an Employment Agency and an Employment Business)...
Technojobs - 11 months ago
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