1 result for Quality Assurance Tester in Richardson, TX

Quality Director

Dallas, TX
onsite
Permanent
150000 - 160000 USD / Yearly
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.
2026-02-23T00:00:00Z