Vice President of Quality

Vice President of Quality

Background:

The Vice President of Quality is responsible for all aspects of the company’s quality assurance, quality compliance, quality control, validation, and supplier quality. The VP, Quality drives compliance with all company and regulatory requirement and manages and coordinates the activities and operations of the quality staff.

Project:

• Directs and coordinates the activities of the quality function to ensure achievement of company objectives.
• Ensures the quality system requirements are maintained and reported.
• Evaluates current procedures and practices for accomplishing department objectives; develops and implements improvements as needed.
• Develops and implements primary quality control systems consistent with GXP (GMP, GLP, GCP) and SOPs.
• Generates protocols, reports, and SOPs; reviews protocols, SOPs, product specifications, and batch records.
• Ensures that cGMPs are always met.
• Directs and coordinates analysis of products in compliance with cGMP regulations and SOPs.
• Identifies technical problems and develops solutions.
• Manages and holds accountable the individuals who review all data generated in support of method validation and stability studies; oversees preparation of technical reports and summaries based on data.
• Oversees completion of appropriate documentation to support testing procedures.
• Develops and maintains department budget.
• Leads GMP audits.
• Hires, trains, supervises, motivates, and develops quality control staff; manages schedules and workflow.
• Assigns duties and monitors quality of work; assures staff conforms to organizational policies and procedures and government regulations.
• Provides day-to-day guidance and oversight of subordinates; actively works to promote and recognize performance.
• Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.
• Demonstrates leadership to organization through communication, development of direct reports, transparency, trustworthiness, and development and support of strategic vision.
• Provides developmental plans and activities for direct reports.
• Acts on behalf of the company as the Management Representative
• Performs other related duties as assigned by management.

Required Skills:

• Ph.D./M.S. in related field and minimum 5 years related experience or B.S. in related field and minimum of 10 years of experience
• Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product/process validation.
• Thorough knowledge of GMP, CFR, and factors impacting compliance.
• Knowledge of and ability to utilize statistic in evaluation of data.
• Thorough knowledge of FDA regulations
• Experience with laboratory environment, equipment, and safety procedures.
• Experience in research and development, including understanding of statistical analysis
• Demonstrated proficiency in supervising and motivating subordinates