Director, Quality

Mallinckrodt Pharmaceuticals
United States, Louisiana, Baton Rouge
Aug 15, 2025
Job Title Director, Quality Requisition JR000015170 Director, Quality (Open) Location Port Allen, LA Additional Locations Job Description Summary Job Description The Director, Quality is responsible for ensuring cGMP compliance and product quality at the Port Allen, LA facility while supporting broader site quality initiatives aligned with company objectives. This role provides strategic leadership in the development, implementation, and oversight of site quality systems to ensure that all manufacturing, testing, packaging, storage, and distribution activities meet regulatory standards and deliver the highest product quality. The Director leads and mentors quality assurance and quality control teams, oversees daily quality operations, and serves as a key partner to site leadership by providing guidance on quality and compliance across the organization. Essential Functions Lead, mentor, and develop supervisors and staff, ensuring all personnel are fully trained, competent, and supported in their roles Establish departmental and site-wide quality objectives, align them with organizational goals, and manage staff performance through regular feedback and evaluations Maintain safe, clean, and compliant work environments across all quality department areas Ensure site quality systems and activities adhere to FDA, cGMP, OSHA, EPA, ISO, and company standards and policies Provide oversight and guidance through documentation review and approval, project assessments, and the development of improvement plans based on performance metrics Lead and facilitate all external audits and regulatory inspections at the Port Allen site Prepare and manage the department's annual budget Support staff growth and retention through development plans, performance assessments, and succession planning Minimum Requirements Bachelor's degree or higher 10+ years of experience in Pharmaceuticals and/or Medical Devices Experience leading regulatory inspections and ensuring compliance Strong strategic planning, financial acumen, and global communication skills Demonstrated ability to lead, motivate, and develop high-performing teams Deep knowledge of cGMPs, regulations, and site processes Proven success driving manufacturing improvements, budget management, and capacity planning Excellent organizational, interpersonal, and communication skills Organizational Relationship/Scope: Reports to the Vice President, Global Quality. This position directly supports Manufacturing, Materials Management, Quality Control, Product Monitoring, Compliance functions and Supply Chain functions. Working Conditions: The position typically works in an office setting, with interaction in the manufacturing areas. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. #LI-LM1