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We are looking for an experienced Quality Director to lead and manage the Quality Unit in a sterile drug manufacturing environment. This role involves ensuring compliance with regulatory standards, overseeing quality operations, and serving as the primary expert in aseptic manufacturing and pharmaceutical distribution. The ideal candidate will bring strategic leadership and technical expertise to maintain high-quality standards and regulatory adherence.
Job Responsibility:
Lead the Quality Unit to ensure compliance with all regulatory standards for 503B Outsourcing Facilities and sterile drug manufacturing
Oversee quality operations, including aseptic manufacturing processes and wholesale pharmaceutical distribution
Represent the organization during audits and inspections conducted by regulatory agencies and third-party auditors
Manage documentation processes, including batch records, ensuring compliance with cGMP and aseptic protocols
Develop and implement quality systems for deviation management, change control, investigations, and product recalls
Approve validation protocols, qualification reports, and standard operating procedures to meet regulatory requirements
Ensure adherence to guidelines for handling hazardous drugs and sterile preparations
Maintain compliance with state and federal regulations governing wholesale drug distribution
Drive continuous quality improvement initiatives and risk management strategies
Provide technical expertise and leadership in sterile manufacturing and quality assurance practices
Requirements:
Bachelor’s degree in Engineering, Life Sciences, or a related field
advanced degrees such as M.S. or Pharm.D. are preferred
A minimum of 8 years of experience in aseptic processing and sterile drug manufacturing
At least 5 years of leadership or management experience in a pharmaceutical manufacturing setting
Comprehensive knowledge of 503B Outsourcing Facility requirements, including cGMP principles and sterility testing
Familiarity with USP , USP , and USP standards
Proven track record of successfully managing regulatory inspections and audits
Expertise in state and federal pharmacy regulations related to outsourcing facilities and drug distribution
Strong skills in quality assurance, risk management, and regulatory compliance