The Director of Quality Systems is responsible for the Quality System as they relate to Investigations, Training and Auditing of suppliers and third party manufacturers. The Director must have sufficient experience in manufacturing pharmaceutical products and understand industry standards to appropriately evaluate practices and procedures and be very familiar with various types of manufacturing technologies including oral solid dose, oral liquid, topical and sterile pharmaceutical products.The experience should include specific technologies such as wet granulation, fluid bed coating, high speed compression, encapsulation, tablet coating, and sterilization techniques such as steam, dry heat, filtration, Ethylene Oxide and Gamma Irradiation.The qualified candidate has appropriate experience in dealing with Governmental officials within the FDA at the District and Center levels.Additional areas of responsibility include evaluating staffing needs, establishing requirements as per GMP and European standards, budget, training, prioritizing and scheduling of team activities and reporting quality progress on a weekly basis to site management.This position must assure all GMP systems are of the highest quality and meet all applicable standards.
ESSENTIAL JOB RESULTS
- · Responsible for implementing and maintaining a compliant Quality System per FDA and ISO requirements
- · Oversee these quality systems within Novel: manufacturing, GMP documentation, quality records management, Validation, change control, calibration, labeling & packaging, product assessment and disposition, warehouse and distribution.
- · Provides assurance that SOPs and practices within the manufacturing, testing, holding and distribution areas are adhered to and are appropriately maintained
- · Responsible for assuring compliance of products manufactured in Novel’s plant in Somerset.
- · Assure GMP requirements are met and appropriate documentation is maintained
- · Promote organization’s growth and adherence to industry standards
- · Ensures all company procedures, policies and systems are in accordance to industry regulations.
- · Direct the development and implementation of departmental goals and objectives.
- · Reporting on the performance of the quality system to corporate representatives and internal management.
- · Coordinates, prepares, participates & responds to FDA, Foreign regulatory agencies and third party inspections.
REQUIRMENTS
Education
Minimum Bachelor Degree in a scientific or technical field; graduate degree desired.
Experience:
- · 9+ years’ experience in a Quality and/or Regulatory management position in pharmaceutical manufacturing, preferably with some experience in aseptic processing.
- · Working knowledge of FDA and applicable non-US regulations pertaining to pharmaceutical drug manufacturing
- · Excellent managerial skills; includes project management, problem-solving, written and verbal communications, and organizational abilities
- · Excellent teamwork, leadership, influencing, and coordinative skills; must be able to work with diverse teams to achieve results
- · The ability to train employees, develop junior managers, and raise process improvement skills and overall quality standards across multiple functions