Director of Regulatory Affairs and Quality System - Pompano Beach, United States - GL Staffing Services

Description

Our clients objective is discovers, develops, and markets vertical integration of pharmaceutical manufacturing and private label skincare. The company manufactures pharmaceutical products to assist physicians with their patients in the areas of dermatology and plastic surgery. The medications are customized to meet the needs of patients that are unable to tolerate commercially available medications.

• Position: Director of Regulatory Affairs and Quality System.
• Direct Hire with excellent benefits
• Schedule: Monday to Friday (8:30 a.m. to 5:00 p.m.)
• 100% job on-site

Job Description:

• Reports and is directly responsible to the Vice President of Scientific Affairs
• Works in close cooperation with PIC/Pharmacists on compliance matters
• Develops and maintains the companys Quality Management System. as it relates to 21 CFR parts 210 and 211 and 503B of the FD&C Act
• Oversees and ensures regulatory compliance with all local state, federal and international regulatory agencies
• Directs and oversees all activities that implement policies related to regulatory matters applicable to the compounding of drug products
• Approves or rejects all procedures, specifications, controls, test methods, and results that impact the purity, quality, and composition of ingredients or products
• Ensures training and compliance to the most current versions of SOPs, cGMPs and related company policies
• Creates, revises and/or approves quality-related procedures, policies and controlled documentation as needed
• Conducts/audits staff training classes
• Responsible for investigating and evaluating customer complaints and/or reported adverse events
• Oversees document control and document changes
• Maintains SOPs and other controlled documentation
• Oversee management of the validation program
• Oversees management of the equipment calibration program
• Oversees approval of all contract laboratories
• Responsible for approving suppliers of critical materials and services
• Oversees a documented sample retention program for finished products
• Oversees non-conformances investigations and implementation of CAPAs

Experience & Qualifications:

• Bachelors Degree in Science
• 10 years or more GMP .
• QA/QC related job experience or equivalent mix of education and experience.
• Extensive knowledge in GMP requirements including 21 CFR parts 210 and 211 and 503B of the FD&C Act.
• Excellent written and spoken English.
• Ability to read, analyze and interpret complex documents.
• Ability to respond effectively to the most sensitive inquiries or complaints.
• Ability to write technical documentation.
• Ability to make effective and persuasive presentations.
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with non-verbal symbolism (such as formulas, scientific equations, graphs, etc.) Identifies and understands issues, problems, and opportunities; compares data from different sources to draw conclusions.