Job Information
Robert Half Quality Director in Dallas, Texas
Description 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.
Responsibilities:
• 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.
Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.
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All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.
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