2 results for Quality Assurance in Plano, 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

Manager, Risk & Assurance

Dallas, TX
onsite
Contract / Temporary to Hire
48 - 57 USD / Hourly
We are looking for a motivated and experienced Manager, Risk & Assurance to join a dynamic team in the financial services industry. This role focuses on conducting comprehensive risk assessments, operational reviews, and process improvement initiatives to enhance governance and efficiency. As a contract-to-permanent position based in Dallas, Texas, it offers hybrid work flexibility, long-term career growth opportunities, and direct exposure to senior leadership. Responsibilities:• Lead and oversee operational, financial, and compliance review projects, ensuring thorough analysis and actionable outcomes.• Design project scopes, perform risk assessments, and develop tailored procedures to address identified risks.• Evaluate business processes and recommend control enhancements to improve efficiency and governance.• Present findings and strategic recommendations to senior leadership in a clear and impactful manner.• Apply detail-oriented auditing standards and leverage sound business judgment throughout all engagements.• Collaborate with cross-functional teams and build strong relationships with stakeholders.• Drive continuous improvement efforts, incorporating data analytics and emerging auditing tools.• Provide advisory support to strengthen organizational risk management strategies.• Ensure adherence to compliance requirements while maintaining a focus on operational enhancement.• Utilize expertise in risk management frameworks, due diligence, and anti-money laundering practices.
2026-03-03T00:00:00Z