Director of Regulatory Affairs and Quality System
3 weeks ago
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 company’s 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 SOP’s 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:
Bachelor’s 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.
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